Document text
Page 1 of 429
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933088
Page 2 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/13/2020
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933089
Page 3 of 429
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11261017]
2.Birth Date: 1985
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933090
Page 4 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933091
Page 5 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933092
Page 6 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933093
Page 7 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Major Depression, in full remission]
Start Date: Mar/21/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Migraine with Aura]
Start Date: Jul/15/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Intermittent Asthma]
Start Date: Mar/31/2015
Ongoing: NO
End Date:
Mar/1/2018
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Insect Venom Allergic Reaction]
Start Date: Mar/13/2015
Ongoing: NO
End Date:
Mar/20/2015
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypertension]
Start Date: Jun/18/2015
Ongoing: NO
End Date:
Jun/1/2016
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933094
Page 8 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Iron Deficiency without Anemia]
Start Date: Oct/1/2015
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Coagulopathy, Unspecified Type]
Start Date: Mar/1/2019
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Cervical High Risk HPV test positive]
Start Date: Apr/5/2019
Ongoing: NO
End Date:
Jun/28/2019
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Allergy to Bee Venom]
Start Date: Mar/13/2015
Ongoing: YES
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933095
Page 9 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [59.1]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [22.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933096
Page 10 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/13/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933097
Page 11 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [48228]
3.Randomization Group: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933098
Page 12 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP567K]
5.bSample ID [BP567L]
5.cSample ID [BP567M]
5.dSample ID [BPRVZJ]
5.eSample ID [BPRVZK]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933099
Page 13 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP56KB]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933100
Page 14 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/13/2020 12:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933101
Page 15 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933102
Page 16 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933103
Page 17 of 429
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933104
Page 18 of 429
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933105
Page 19 of 429
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933106
Page 20 of 429
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933107
Page 21 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP56NW]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933108
Page 22 of 429
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/1/2020 12:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933109
Page 23 of 429
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933110
Page 24 of 429
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933111
Page 25 of 429
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933112
Page 26 of 429
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP28JN]
5.bSample ID [BPRW98]
5.cSample ID [BLC38N]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933113
Page 27 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933114
Page 28 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/21/2020
2.Date of First Symptom Started: Oct/20/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/20/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933115
Page 29 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Col
lectionSpecimen TypeSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/20/202
0 SWABBED MA
TERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933116
Page 30 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/20/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CORONAVIR PAN-2019 NCOV, NAA, QL (KAISER CLIA LAB)]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933117
Page 31 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW82931]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933118
Page 32 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933119
Page 33 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: YES
Number of Visits or Contacts:
[1]
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]
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933120
Page 34 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933121
Page 35 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933122
Page 36 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933123
Page 37 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933124
Page 38 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933125
Page 39 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1.Not Done Not Done Not Done Not Done Sponsor-Defined Iden
tifierTest:Result:
Not Done Not Don
e Not Don
e
Not Done Not Don
e Not Don
e
Not Done Not Don
e Not Don
e
Not Done Not Don
e Not Don
e
Not Done Not Don
e Not Don
e
Not Done Not Don
e Not Don
e
Not Done Not Don
e Not Don
e Repeating
Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933126
Page 40 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933127
Page 41 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933128
Page 42 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933129
Page 43 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933130
Page 44 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for La
b TestVendor Name (DER
IVED)Collection
Date:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933131
Page 45 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933132
Page 46 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933133
Page 47 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933134
Page 48 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933135
Page 49 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933136
Page 50 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933137
Page 51 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
1.Oct/20/2020 Record Identifier: Systolic: Diastolic:
1 141 92 Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933138
Page 52 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [141]
Diastolic: [92]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [99]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933139
Page 53 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
1.Oct/20/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933140
Page 54 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/20/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933141
Page 55 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933142
Page 56 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933143
Page 57 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1.Not Done Not Done Not Done Not Done Not Don
e Repeating
Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933144
Page 58 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933145
Page 59 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933146
Page 60 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933147
Page 61 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/24/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933148
Page 62 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/24/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/24/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZZ04]
5.bSample ID [BLC38G]
5.cSample ID [BLC3HW]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933149
Page 63 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/24/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933150
Page 64 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/24/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933151
Page 65 of 429
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933152
Page 66 of 429
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933153
Page 67 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933154
Page 68 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933155
Page 69 of 429
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 Acute sinusitis Aug/15/2020 04:0
0 NO
End Date Time:
Aug/20/2020 12:00
Repeating
Pages
2.ADVERSE EV
ENT 2 VACCINE ALLERGIC REA
CTION Jan/7/2021 11:37 NO
End Date Time:
Jan/8/2021 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Facial Flushing Jan/7/2021 11:37 NO
End Date Time:
Jan/8/2021 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 Facial swelling Jan/7/2021 11:37 NO
End Date Time:
Jan/8/2021 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 Hives, abdomen Jan/7/2021 14:50 NO
End Date Time:
Jan/8/2021 UNK:UNK
Repeating
Pages
6.ADVERSE EV
ENT 6 Nausea Jan/7/2021 12:50 NO
End Date Time:
Jan/7/2021 14:00
Repeating
Pages
7.ADVERSE EV
ENT 7 Muscle aches Jan/8/2021 UNK:
UNK NO
End Date Time:
Jan/9/2021 UNK:UNK
Repeating
Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933156
Page 70 of 429
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Acute sinusitis]
4.Start Date Time: Aug/15/2020 04:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/20/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: 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
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933157
Page 71 of 429
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933158
Page 72 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[VACCINE ALLERGIC REACTION]
4.Start Date Time: Jan/7/2021 11:37
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/8/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933159
Page 73 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933160
Page 74 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Facial Flushing]
4.Start Date Time: Jan/7/2021 11:37
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/8/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933161
Page 75 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933162
Page 76 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Facial swelling]
4.Start Date Time: Jan/7/2021 11:37
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/8/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933163
Page 77 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933164
Page 78 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Hives, abdomen]
4.Start Date Time: Jan/7/2021 14:50
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/8/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933165
Page 79 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933166
Page 80 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Nausea]
4.Start Date Time: Jan/7/2021 12:50
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/7/2021 14:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933167
Page 81 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933168
Page 82 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Muscle aches]
4.Start Date Time: Jan/8/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/9/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933169
Page 83 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933170
Page 84 of 429
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
1. Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933171
Page 85 of 429
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933172
Page 86 of 429
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of MedicationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO Influenza vaccine (Fluarix q
uadrivalent) Sep/21/2
020 Repeating
Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933173
Page 87 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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).[Influenza vaccine (Fluarix quadrivalent)]
5.Date: Sep/21/2020
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933174
Page 88 of 429
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933175
Page 89 of 429
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933176
Page 90 of 429
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933177
Page 91 of 429
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933178
Page 92 of 429
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933179
Page 93 of 429
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933180
Page 94 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933181
Page 95 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933182
Page 96 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933183
Page 97 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933184
Page 98 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933185
Page 99 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933186
Page 100 of 429
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933187
Page 101 of 429
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933188
Page 102 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933189
Page 103 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/7/2021
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933190
Page 104 of 429
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933191
Page 105 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/7/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933192
Page 106 of 429
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933193
Page 107 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [BPZZ7S]
5.bSample ID [BS7VKR]
5.cSample ID [BLC3LV]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933194
Page 108 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [BP294K]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933195
Page 109 of 429
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/7/2021 11:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933196
Page 110 of 429
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/21/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933197
Page 111 of 429
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933198
Page 112 of 429
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933199
Page 113 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933200
Page 114 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933201
Page 115 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BR7YWY]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933202
Page 116 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933203
Page 117 of 429
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933204
Page 118 of 429
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/25/2021
3.Comments: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933205
Page 119 of 429
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933206
Page 120 of 429
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933207
Page 121 of 429
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933208
Page 122 of 429
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933209
Page 123 of 429
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/28/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933210
Page 124 of 429
***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/1/2020
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933211
Page 125 of 429
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933212
Page 126 of 429
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nicola Klein Approved Mar-08-2021 16:43:05 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933213
Page 127 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-13-2020 13:58:01 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933214
Page 128 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 19:55:24 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933215
Page 129 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-21-2020 19:55:24 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933216
Page 130 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-21-2020 19:55:24 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933217
Page 131 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-21-2020 19:55:24 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933218
Page 132 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-21-2020 19:55:24 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933219
Page 133 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Oct-21-2020 19:55:24 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933220
Page 134 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Oct-21-2020 19:55:24 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933221
Page 135 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 19:54:40 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933222
Page 136 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-21-2020 19:54:40 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933223
Page 137 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-21-2020 19:54:40 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933224
Page 138 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-21-2020 19:54:40 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933225
Page 139 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-21-2020 19:54:40 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933226
Page 140 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 19:55:38 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933227
Page 141 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada) )Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933228
Page 142 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933229
Page 143 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933230
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Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933231
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933232
Page 146 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933233
Page 147 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933234
Page 148 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933235
Page 149 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933236
Page 150 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933237
Page 151 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933238
Page 152 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933239
Page 153 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933240
Page 154 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933241
Page 155 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933242
Page 156 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933243
Page 157 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933244
Page 158 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933245
Page 159 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933246
Page 160 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933247
Page 161 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933248
Page 162 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933249
Page 163 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933250
Page 164 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933251
Page 165 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933252
Page 166 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933253
Page 167 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933254
Page 168 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933255
Page 169 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933256
Page 170 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933257
Page 171 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933258
Page 172 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:38 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933259
Page 173 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 19:55:53 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933260
Page 174 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933261
Page 175 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933262
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933263
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933264
Page 178 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933265
Page 179 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933266
Page 180 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933267
Page 181 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933268
Page 182 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933269
Page 183 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933270
Page 184 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933271
Page 185 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933272
Page 186 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933273
Page 187 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933274
Page 188 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933275
Page 189 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933276
Page 190 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933277
Page 191 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933278
Page 192 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933279
Page 193 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933280
Page 194 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933281
Page 195 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933282
Page 196 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933283
Page 197 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933284
Page 198 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933285
Page 199 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933286
Page 200 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933287
Page 201 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 fOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933288
Page 202 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933289
Page 203 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933290
Page 204 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933291
Page 205 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933292
Page 206 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 hOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933293
Page 207 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 hOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933294
Page 208 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 hOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933295
Page 209 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5 hOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933296
Page 210 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933297
Page 211 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933298
Page 212 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933299
Page 213 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933300
Page 214 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933301
Page 215 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933302
Page 216 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933303
Page 217 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-21-2020 19:55:53 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933304
Page 218 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 19:57:07 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933305
Page 219 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-21-2020 19:57:07 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933306
Page 220 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-21-2020 19:57:07 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933307
Page 221 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-21-2020 19:57:07 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933308
Page 222 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 19:57:18 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933309
Page 223 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-21-2020 19:57:18 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933310
Page 224 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-21-2020 19:57:18 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933311
Page 225 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-21-2020 19:57:18 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933312
Page 226 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-21-2020 19:57:18 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933313
Page 227 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Oct-21-2020 19:57:18 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933314
Page 228 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Oct-21-2020 19:57:18 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933315
Page 229 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-21-2020 19:57:30 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933316
Page 230 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-21-2020 19:57:30 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933317
Page 231 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-21-2020 19:57:30 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933318
Page 232 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-21-2020 19:57:30 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933319
Page 233 of 429
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-21-2020 19:57:30 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933320
Page 234 of 429
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-25-2020 15:12:16 (UTC-08:00) Pacific Time
(US & Canada)Data entry error, visit has not occurred
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933321
Page 235 of 429
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-08-2021 13:07:38 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933322
Page 236 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-29-2021 12:38:54 (UTC-08:00) Pacific Time
(US & Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933323
Page 237 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Jan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933324
Page 238 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Jan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933325
Page 239 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Jan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933326
Page 240 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Jan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933327
Page 241 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Jan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933328
Page 242 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6.aJan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933329
Page 243 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6.aJan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933330
Page 244 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6.aJan-29-2021 12:38:54 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933331
Page 245 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-01-2021 13:56:21 (UTC-08:00) Pacific Time
(US & Canada)Subject did not get vaccinated. Due to meeting
Exclusion Criteria # 3.
FormFeb-11-2021 08:13:23 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933332
Page 246 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
1Feb-04-2021 12:21:40 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933333
Page 247 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933334
Page 248 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933335
Page 249 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
4Feb-02-2021 14:59:22 (UTC-08:00) Pacific Time (US
& Canada)Not Done
4Jan-29-2021 12:42:05 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933336
Page 250 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933337
Page 251 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
6Feb-02-2021 14:59:35 (UTC-08:00) Pacific Time (US
& Canada)Not Done
6Jan-29-2021 12:40:59 (UTC-08:00) Pacific Time (US
& Canada)N/A
Not Applicable
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933338
Page 252 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933339
Page 253 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
8Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933340
Page 254 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
9Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933341
Page 255 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
10Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933342
Page 256 of 429
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
11Feb-11-2021 08:13:23 (UTC-08:00) Pacific Time (US
& Canada)Not Done
11Feb-08-2021 17:35:17 (UTC-08:00) Pacific Time (US
& Canada)Not Done
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933343
Page 257 of 429
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nicola Klein Approved Mar-08-2021 16:43:05 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-29-2021 12:38:04 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nicola Klein Approved Jan-22-2021 10:56:51 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-27-2020 21:40:11 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nicola Klein Approved Dec-01-2020 13:54:27 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933344
Page 258 of 429
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-25-2020 15:11:41 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nicola Klein Approved Oct-22-2020 14:59:43 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-21-2020 19:52:13 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nicola Klein Approved Oct-13-2020 12:11:54 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Charlie Chao N/A Oct-01-2020 16:52:37 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933345
Page 259 of 429
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
N/A
Nicola Klein Approved Sep-10-2020 16:02:02 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933346
Page 260 of 429
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-13-2020 13:57:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020 13:57:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933347
Page 261 of 429
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020 13:57:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/13/2020Initial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933348
Page 262 of 429
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020 13:57:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11261017Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 13:57:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1985Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 13:57:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 13:57:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020 13:57:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933349
Page 263 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020 13:57:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933350
Page 264 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-13-2020 13:58:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 13:58:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 13:58:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933351
Page 265 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 13:58:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Major Depression, in f
ull remission
Start Date: Mar/21/2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 13:58:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 13:58:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Major Depression, in full remissionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 13:58:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/21/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 13:58:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-13-2020 13:58:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933352
Page 266 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical History Ter
m:Migraine with A
ura
Start Date: Jul/15/2018
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020 13:58:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 13:58:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Migraine with AuraInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 13:58:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/15/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020 13:58:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-13-2020 13:59:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Intermittent Asth
ma
Start Date: Mar/31/2015
Ongoing: NO
End Date:
Mar/1/2018Initial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933353
Page 267 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 13:59:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 13:59:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Intermittent AsthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 13:59:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/31/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 13:59:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/1/2018Initial Entry
1.d
Date Location User Value Reason
Aug-13-2020 14:00:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:Insect Venom Allergic
Reaction
Start Date: Mar/13/2015
Ongoing: NO
End Date:
Mar/20/2015Initial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933354
Page 268 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 14:00:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 14:00:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Insect Venom Allergic ReactionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 14:00:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/13/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 14:00:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/20/2015Initial Entry
1.e
Date Location User Value Reason
Aug-13-2020 14:02:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Term: Hypertension
Start Date: Jun/18/2015
Ongoing: NO
End Date:
Jun/1/2016Initial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933355
Page 269 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 14:02:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 14:02:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 14:02:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/18/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 14:02:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/1/2016Initial Entry
1.f
Date Location User Value Reason
Aug-13-2020 14:02:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical Histor
y Term:Iron Deficiency witho
ut Anemia
Start Date: Oct/1/2015
Ongoing: YESInitial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933356
Page 270 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 14:02:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 14:02:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Iron Deficiency without AnemiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 14:02:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 14:02:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-13-2020 14:03:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Coagulopathy, Unspe
cified Type
Start Date: Mar/1/2019
Ongoing: YESInitial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933357
Page 271 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020 14:03:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:49:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Carlos Linn Query 1: Closed Response satisfies query
Aug-18-2020 18:56:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject has low Von
Willibrand Antigen level
but did not meet criteria
for diagnosis.
Aug-18-2020 10:28:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Carlos Linn Query 1: Opened Please clarify more in
term of "coagulopathy,
unspecific type?" any
immunocompromised
state related with the
coagulopathy?
Aug-13-2020 14:03:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Coagulopathy, Unspecified TypeInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020 14:03:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020 14:03:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-13-2020 14:03:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8Initial Entry
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933358
Page 272 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1126 Site Name: (1126) Kaiser Permanente Santa Clara
Subject No: 11261017 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical Histo
ry Term:Cervical High Risk HP
V test positive
Start Date: Apr/5/2019
Ongoing: NO
End Date:
Jun/28/2019
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020 14:03:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 14:03:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cervical High Risk HPV test positiveInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020 14:03:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/5/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020 14:03:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/28/2019Initial Entry
1.i
Date Location User Value Reason
Aug-14-2020 08:10:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number
:9
Medical History T
erm:Allergy to Bee Ve
nom
Start Date: Mar/13/2015New Information
090177e196ae3d4e\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933359
Page 273 of 429
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22
…[truncated]