125742 45 S211 M5 c4591001 1270 12701237

Document text

Page 1 of 1152
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497979
Page 2 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/7/2021
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497980
Page 3 of 1152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [12701237]
2.Birth Date: 2007
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497981
Page 4 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497982
Page 5 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497983
Page 6 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/7/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497984
Page 7 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Vitamin D Deficiency]
Start Date: Jun/22/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: Aug/23/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Asthma]
Start Date: Feb/1/2016
Ongoing: YES
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497985
Page 8 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: Dec/2/2014
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Pectus Carinatum]
Start Date: Dec/30/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Right foot pain]
Start Date: Dec/18/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bilateral temporomandibular joint pain]
Start Date: Nov/16/2020
Ongoing: YES
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497986
Page 9 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergy to Vancomycins]
Start Date: Dec/30/2020
Ongoing: YES
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497987
Page 10 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497988
Page 11 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/7/2021
2.Weight: [69.7]
3.Unit: kg
4.Height: [160.0]
5.Unit: cm
6.Body Mass Index: [27.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497989
Page 12 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/7/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497990
Page 13 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/7/2021
2.Randomization Number: [25675]
3.Randomization Group: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497991
Page 14 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [BR33C7]
5.bSample ID [BR33C6]
5.cSample ID [BK5M31]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497992
Page 15 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [BR33CK]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497993
Page 16 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/7/2021 09:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497994
Page 17 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497995
Page 18 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497996
Page 19 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Jan/14/2021
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497997
Page 20 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497998
Page 21 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497999
Page 22 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Feb/17/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498000
Page 23 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/17/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498001
Page 24 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
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 [BRFFLC]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498002
Page 25 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
ObservedNot Done Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498003
Page 26 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?Not Done Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498004
Page 27 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/23/2021
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498005
Page 28 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498006
Page 29 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498007
Page 30 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498008
Page 31 of 1152
***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, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/23/2021
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 [BJRMMT]
5.bSample ID [BJRMMV]
5.cSample ID [BK5HWR]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498009
Page 32 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498010
Page 33 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/20/2021
2.Date of First Symptom
Started:Jan/19/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/20/2021
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498011
Page 34 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498012
Page 35 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Jan/24/
2021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498013
Page 36 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/24/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection
Location:NASOPHARYNX Comments
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings
/Details:[ ] Comments
9.Trade Name Other, Specify: [SARS COV2 TEST CLIA CERT LAB] Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498014
Page 37 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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/21/2021
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 [RR10814]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498015
Page 38 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:[SEE SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498016
Page 39 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498017
Page 40 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO Comments
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ] Comments
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498018
Page 41 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
 1.Not Applicab
le Not Applicable  Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498019
Page 42 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498020
Page 43 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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/24/2021
3.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498021
Page 44 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498022
Page 45 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498023
Page 46 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab TestVendor
NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Done  Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498024
Page 47 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot 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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498025
Page 48 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498026
Page 49 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498027
Page 50 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498028
Page 51 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498029
Page 52 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498030
Page 53 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498031
Page 54 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.Not Done  Not Done  Not Do
ne Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498032
Page 55 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498033
Page 56 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot 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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498034
Page 57 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498035
Page 58 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498036
Page 59 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498037
Page 60 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498038
Page 61 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498039
Page 62 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498040
Page 63 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498041
Page 64 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498042
Page 65 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498043
Page 66 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498044
Page 67 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in
beats/minute:Not Applicable
[ ]Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498045
Page 68 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498046
Page 69 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498047
Page 70 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498048
Page 71 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498049
Page 72 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
 1.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498050
Page 73 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable 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 Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498051
Page 74 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.Not Applicable  Not Applicable  Not Applicabl
e Not Applicable  Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498052
Page 75 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/20/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498053
Page 76 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498054
Page 77 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/29/2021
2.Date of First Symptom
Started:Jan/26/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/26/2021
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? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498055
Page 78 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498056
Page 79 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498057
Page 80 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498058
Page 81 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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/29/2021
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 [RR26586]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498059
Page 82 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:[SEE SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498060
Page 83 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:YES
Number of Visits or Contacts:
[1]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498061
Page 84 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498062
Page 85 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498063
Page 86 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498064
Page 87 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?NO
3.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498065
Page 88 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498066
Page 89 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498067
Page 90 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab TestVendor
NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Done  Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498068
Page 91 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot 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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498069
Page 92 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498070
Page 93 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498071
Page 94 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498072
Page 95 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498073
Page 96 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498074
Page 97 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498075
Page 98 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.Not Done  Not Done  Not Do
ne Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498076
Page 99 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498077
Page 100 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot 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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498078
Page 101 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498079
Page 102 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498080
Page 103 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498081
Page 104 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498082
Page 105 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498083
Page 106 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498084
Page 107 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498085
Page 108 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498086
Page 109 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498087
Page 110 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498088
Page 111 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498089
Page 112 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498090
Page 113 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498091
Page 114 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.Not Done  Not Done  Not Done  Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498092
Page 115 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498093
Page 116 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not D
one Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498094
Page 117 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498095
Page 118 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498096
Page 119 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/29/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498097
Page 120 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498098
Page 121 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jul/1/2021
2.Date of First Symptom
Started:Jun/24/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jul/6/2021
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? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498099
Page 122 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Left ear pain]
5.bSymptoms - Other Text: [Nasal congestion]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498100
Page 123 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Jun/30/
2021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498101
Page 124 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jun/30/2021
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: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [SARS-COV-2 TEST CLIA CERIFIED LAB]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498102
Page 125 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jul/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 [RR11552]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498103
Page 126 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:[SEE SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498104
Page 127 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498105
Page 128 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498106
Page 129 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498107
Page 130 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498108
Page 131 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:
[Sinus Infection]
Date of Diagnosis:
Jun/30/2021
3.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498109
Page 132 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498110
Page 133 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498111
Page 134 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab TestVendor
NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Done  Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498112
Page 135 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot 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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498113
Page 136 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498114
Page 137 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498115
Page 138 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498116
Page 139 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498117
Page 140 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498118
Page 141 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498119
Page 142 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.Not Done  Not Done  Not Do
ne Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498120
Page 143 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498121
Page 144 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot 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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498122
Page 145 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498123
Page 146 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498124
Page 147 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498125
Page 148 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498126
Page 149 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498127
Page 150 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498128
Page 151 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498129
Page 152 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498130
Page 153 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498131
Page 154 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498132
Page 155 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498133
Page 156 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498134
Page 157 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498135
Page 158 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.Not Done  Not Done  Not Done  Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498136
Page 159 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498137
Page 160 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not D
one Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498138
Page 161 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498139
Page 162 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498140
Page 163 of 1152
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498141
Page 164 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498142
Page 165 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
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 [BRFFL4]
5.bSample ID [BK5HS9]
5.cSample ID [BRFFL5]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498143
Page 166 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/04/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498144
Page 167 of 1152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Mar/04/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/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 [BRFFPT]
5.bSample ID [BK5HT2]
5.cSample ID [BRFFPV]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498145
Page 168 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498146
Page 169 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498147
Page 170 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498148
Page 171 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498149
Page 172 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498150
Page 173 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498151
Page 174 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498152
Page 175 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498153
Page 176 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498154
Page 177 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498155
Page 178 of 1152
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jan/26/2021
2.Phase of Disposition: VACCINATION
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [EC#55: Participant had a positive local COVID-19 test before
Vx2, symptomatic with test]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498156
Page 179 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/14/2021
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498157
Page 180 of 1152
***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
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498158
Page 181 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Jul/13/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Subject declines to participate in further study activities.]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498159
Page 182 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoi
ngForm Insta
nce
 1.ADVER
SE EVE
NT 1 Rib pain on right side  Feb/10/202
1 UNK:UN
K NO
End Date Time:
Mar/10/2021
UNK:UNK
 Repeating
Pages
 2.ADVER
SE EVE
NT 2 Rash on Right Foot  Apr/5/2021
UNK:UNK
 NO
End Date Time:
Apr/8/2021 U
NK:UNK
 Repeating
Pages
 3.ADVER
SE EVE
NT 3 Fever  May/20/20
21 UNK:U
NK NO
End Date Time:
May/21/2021
UNK:UNK
 Repeating
Pages
 4.ADVER
SE EVE
NT 4 CHILLS  May/19/20
21 UNK:U
NK NO
End Date Time:
May/21/2021
UNK:UNK
 Repeating
Pages
 5.ADVER
SE EVE
NT 5 INTERMITTENT HEA
DACHES May/19/20
21 UNK:U
NK NO
End Date Time:
Jul/13/2021 URepeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498160
Page 183 of 1152
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoi
ngForm Insta
nce
NK:UNK
 
 6.ADVER
SE EVE
NT 6 INTERMITTENT NON-
CARDIAC CHEST DIS
COMFORT May/19/20
21 UNK:U
NK NO
End Date Time:
Jul/13/2021 U
NK:UNK
 Repeating
Pages
 7.ADVER
SE EVE
NT 7 INTERMITTENT NAUS
EA May/19/20
21 UNK:U
NK NO
End Date Time:
Jul/13/2021 U
NK:UNK
 Repeating
Pages
 8.ADVER
SE EVE
NT 8 LOSS OF APPETITE  May/25/20
21 UNK:U
NK NO
End Date Time:
Jul/13/2021 U
NK:UNK
 Repeating
Pages
 9.ADVER
SE EVE
NT 9 INCREASED THIRST  May/25/20
21 UNK:U
NK NO
End Date Time:
Jun/12/2021
UNK:UNK
 Repeating
Pages
 10.ADVER
SE EVE
NT 10 INTERMITTENT STO
MACH PAIN May/25/20
21 UNK:U
NK NO
End Date Time:Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498161
Page 184 of 1152
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoi
ngForm Insta
nce
Jul/13/2021 U
NK:UNK
 
 11.ADVER
SE EVE
NT 11 FATIGUE  May/25/20
21 UNK:U
NK NO
End Date Time:
Jul/13/2021 U
NK:UNK
 Repeating
Pages
 12.ADVER
SE EVE
NT 12 LEFT OTITIS MEDIA  Jun/29/202
1 UNK:UN
K NO
End Date Time:
Jul/6/2021 U
NK:UNK
 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498162
Page 185 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[Rib pain on right side]
4.Start Date Time: Feb/10/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/10/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498163
Page 186 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498164
Page 187 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498165
Page 188 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[Rash on Right Foot]
4.Start Date Time: Apr/5/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Apr/8/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498166
Page 189 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498167
Page 190 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?YES
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[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498168
Page 191 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[Fever]
4.Start Date Time: May/20/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
May/21/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498169
Page 192 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498170
Page 193 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498171
Page 194 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[CHILLS]
4.Start Date Time: May/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
May/21/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498172
Page 195 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498173
Page 196 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498174
Page 197 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[INTERMITTENT HEADACHES]
4.Start Date Time: May/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/13/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498175
Page 198 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498176
Page 199 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498177
Page 200 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[INTERMITTENT NON-CARDIAC CHEST DISCOMFORT]
4.Start Date Time: May/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/13/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498178
Page 201 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498179
Page 202 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498180
Page 203 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[INTERMITTENT NAUSEA]
4.Start Date Time: May/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/13/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498181
Page 204 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498182
Page 205 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498183
Page 206 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[LOSS OF APPETITE]
4.Start Date Time: May/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/13/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498184
Page 207 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498185
Page 208 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498186
Page 209 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[INCREASED THIRST]
4.Start Date Time: May/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/12/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498187
Page 210 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498188
Page 211 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498189
Page 212 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[INTERMITTENT STOMACH PAIN]
4.Start Date Time: May/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/13/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498190
Page 213 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498191
Page 214 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498192
Page 215 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [11]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[FATIGUE]
4.Start Date Time: May/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/13/2021 UNK:UNK
6.Toxicity Grade: 3
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498193
Page 216 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498194
Page 217 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498195
Page 218 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [12]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[LEFT OTITIS MEDIA]
4.Start Date Time: Jun/29/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/6/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498196
Page 219 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498197
Page 220 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?YES
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[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498198
Page 221 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498199
Page 222 of 1152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498200
Page 223 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Def
ined Identifi
erCategory fo
r Medicatio
nConcomitant Med
ications Pre-specif
iedName of Medicati
onStart
DateForm Insta
nce
 1.1  VACCINAT
IONS NO  Fluarix Quadrivale
nt (Influenza Vacci
ne) Dec/2
1/202
0 Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498201
Page 224 of 1152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Fluarix Quadrivalent (Influenza Vaccine)]
5.Date: Dec/21/2020
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498202
Page 225 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498203
Page 226 of 1152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498204
Page 227 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498205
Page 228 of 1152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498206
Page 229 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498207
Page 230 of 1152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498208
Page 231 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498209
Page 232 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498210
Page 233 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498211
Page 234 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/19/2021
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498212
Page 235 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
May/19/2021
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498213
Page 236 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498214
Page 237 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :May/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498215
Page 238 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: May/19/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498216
Page 239 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
May/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 [BJRMV6]
5.bSample ID [BK5J12]
5.cSample ID [BK5J0L]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498217
Page 240 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
May/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 [BJRMVX]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498218
Page 241 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: May/19/2021 09:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498219
Page 242 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498220
Page 243 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and
Address (Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498221
Page 244 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498222
Page 245 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
ObservedNot Done Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498223
Page 246 of 1152
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?Not Done Comments
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498224
Page 247 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498225
Page 248 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498226
Page 249 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498227
Page 250 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498228
Page 251 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498229
Page 252 of 1152
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498230
Page 253 of 1152
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498231
Page 254 of 1152
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jul/13/2021
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498232
Page 255 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498233
Page 256 of 1152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0498234
Page 257 of 1152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-12-2021 12:20:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498235
Page 258 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormFeb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and
Dose 2. Was there a temporary
delay of vaccination? NO.
Not Done
FormFeb-17-2021 15:23:22 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and
Dose 2. Was there a temporary
delay of vaccination? NO.
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498236
Page 259 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498237
Page 260 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498238
Page 261 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498239
Page 262 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498240
Page 263 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498241
Page 264 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498242
Page 265 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498243
Page 266 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498244
Page 267 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498245
Page 268 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
10Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498246
Page 269 of 1152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
11Feb-23-2021 14:29:54 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed due to participant testing
positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2. Was there a temporary delay of
vaccination? NO.
Not Done
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498247
Page 270 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and
Dose 2.
Not Applicable
FormMar-24-2021 09:51:39 (UTC-08:00)
Pacific Time (US & Canada)Charlie Chao Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and
Dose 2.
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0498248
Page 271 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Mar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2.
Not Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498249
Page 272 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.aMar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2.
Not Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498250
Page 273 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.bMar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2.
Not Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498251
Page 274 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.cMar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2.
Not Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498252
Page 275 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.dMar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2.
Not Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498253
Page 276 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.eMar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to participant
testing positive for Covid-19 (with
symptoms) between Dose 1 and Dose
2.
Not Applicable
090177e19891a041\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0498254
Page 277 of 1152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701237 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.fMar-26-2021 10:16:29 (UTC-08:00)
Pacific Time (US & Canada)Per protocol, vaccination not
completed at V2 due to partici
…[truncated]