125742 S1 M5 CRF c4591001 1264 12641229

Document text

Page 1 of 422
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837894
Page 2 of 422
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/27/2020
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837895
Page 3 of 422
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12641229]
2.Birth Date: /1958
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837896
Page 4 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837897
Page 5 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837898
Page 6 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837899
Page 7 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ACL repair, left]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Meniscus tear repair, left]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837900
Page 8 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Meniscus tear repair, right]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Lupus]
Start Date: UNK/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Vasectomy]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837901
Page 9 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837902
Page 10 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
2.Weight: [97.6]
3.Unit: kg
4.Height: [168.7]
5.Unit: cm
6.Body Mass Index: [34.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837903
Page 11 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/27/2020
2.Randomization Number: [273378]
3.Randomization Group: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837904
Page 12 of 422
***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, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BRSSB7]
5.bSample ID [BRSSB8]
5.cSample ID [BM930W]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837905
Page 13 of 422
***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, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BM930V]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837906
Page 14 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/27/2020 14:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837907
Page 15 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837908
Page 16 of 422
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837909
Page 17 of 422
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Nov/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.0]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837910
Page 18 of 422
***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, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM92F5]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837911
Page 19 of 422
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: Nov/16/2020 09:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837912
Page 20 of 422
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837913
Page 21 of 422
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM92JJ]
5.bSample ID [BSGR11]
5.cSample ID [BSGR12]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837914
Page 22 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837915
Page 23 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/10/2020
2.Date of First Symptom
Started:Dec/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/15/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837916
Page 24 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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.aSymptoms - Other Text: [Fatigue]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837917
Page 25 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837918
Page 26 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837919
Page 27 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Subject was currently traveling and did not bring his swab kit,
swab could not be collected until his return home and discharge
from hospital.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RR02460]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837920
Page 28 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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:[Subject was out of the country and subsequently hospitalized,
and swab could not be collected until 17Dec20.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837921
Page 29 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837922
Page 30 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837923
Page 31 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837924
Page 32 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837925
Page 33 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837926
Page 34 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837927
Page 35 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837928
Page 36 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab TestVendor
NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Done  Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837929
Page 37 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837930
Page 38 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837931
Page 39 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837932
Page 40 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837933
Page 41 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837934
Page 42 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837935
Page 43 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837936
Page 44 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.Not Done  Not Done  Not Do
ne Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837937
Page 45 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
Not Done  Not
Done
 Not
Done
 
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837938
Page 46 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837939
Page 47 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837940
Page 48 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837941
Page 49 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837942
Page 50 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837943
Page 51 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837944
Page 52 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837945
Page 53 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837946
Page 54 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837947
Page 55 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837948
Page 56 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837949
Page 57 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in
beats/minute:Not Done
[ ]Comments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837950
Page 58 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837951
Page 59 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837952
Page 60 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837953
Page 61 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837954
Page 62 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
 1.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837955
Page 63 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837956
Page 64 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837957
Page 65 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837958
Page 66 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/14/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837959
Page 67 of 422
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BM92M2]
5.bSample ID [BSGR2Z]
5.cSample ID [BSGR30]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837960
Page 68 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837961
Page 69 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837962
Page 70 of 422
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Pulmonary e
mbolism Dec/7/2020 U
NK:UNK YES  Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837963
Page 71 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Pulmonary embolism]
4.Start Date Time: Dec/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 4
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837964
Page 72 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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:
[Not specified]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837965
Page 73 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020497627]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837966
Page 74 of 422
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837967
Page 75 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837968
Page 76 of 422
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837969
Page 77 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837970
Page 78 of 422
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837971
Page 79 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837972
Page 80 of 422
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837973
Page 81 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837974
Page 82 of 422
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837975
Page 83 of 422
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837976
Page 84 of 422
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837977
Page 85 of 422
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837978
Page 86 of 422
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837979
Page 87 of 422
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837980
Page 88 of 422
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837981
Page 89 of 422
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837982
Page 90 of 422
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837983
Page 91 of 422
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837984
Page 92 of 422
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837985
Page 93 of 422
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 1/2Comments
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837986
Page 94 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837987
Page 95 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837988
Page 96 of 422
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837989
Page 97 of 422
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837990
Page 98 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837991
Page 99 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/27/2021
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837992
Page 100 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837993
Page 101 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837994
Page 102 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BM92MF]
5.bSample ID [BSGR5T]
5.cSample ID [BSGR5V]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837995
Page 103 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BRFH8G]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837996
Page 104 of 422
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/27/2021 16:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837997
Page 105 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837998
Page 106 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4FBC]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837999
Page 107 of 422
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/17/2021 08:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838000
Page 108 of 422
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838001
Page 109 of 422
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838002
Page 110 of 422
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838003
Page 111 of 422
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838004
Page 112 of 422
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838005
Page 113 of 422
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838006
Page 114 of 422
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838007
Page 115 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/18/2020
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838008
Page 116 of 422
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838009
Page 117 of 422
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Albertson Approved Mar-11-2021 14:48:33 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyAlbertson, 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.
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838010
Page 118 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:49:04 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838011
Page 119 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838012
Page 120 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838013
Page 121 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838014
Page 122 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838015
Page 123 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838016
Page 124 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838017
Page 125 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
6Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-14-2020 09:02:40 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:04:02 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:04:02 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:04:02 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0838024
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:04:02 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0838025
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 09:04:02 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838026
Page 134 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-14-2020 09:04:02 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838027
Page 135 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-14-2020 09:04:02 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838028
Page 136 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:22:45 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838029
Page 137 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:22:45 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838030
Page 138 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:22:45 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838031
Page 139 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:22:45 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838032
Page 140 of 422
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 09:22:45 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838033
Page 141 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838034
Page 142 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838035
Page 143 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838036
Page 144 of 422
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CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838037
Page 145 of 422
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CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838038
Page 146 of 422
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CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838039
Page 147 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838040
Page 148 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Page 149 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838042
Page 150 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
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Page 151 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.bDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838044
Page 152 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838045
Page 153 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838046
Page 154 of 422
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Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Page 155 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838048
Page 156 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838049
Page 157 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838050
Page 158 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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ItemDate User Comment
5.dDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838058
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838059
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838060
Page 168 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838061
Page 169 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838062
Page 170 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838063
Page 171 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0838064
Page 172 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0838065
Page 173 of 422
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:06 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838066
Page 174 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838067
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838068
Page 176 of 422
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838069
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838070
Page 178 of 422
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838071
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838082
Page 190 of 422
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Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0838083
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ItemDate User Comment
5.dDec-14-2020 09:06:28 (UTC-08:00)
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090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838085
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838086
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838087
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838088
Page 196 of 422
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838089
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838090
Page 198 of 422
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838091
Page 199 of 422
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838092
Page 200 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838093
Page 201 of 422
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838094
Page 202 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838095
Page 203 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838096
Page 204 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0838097
Page 205 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838098
Page 206 of 422
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0838099
Page 207 of 422
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838100
Page 208 of 422
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Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838101
Page 209 of 422
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Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838102
Page 210 of 422
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838103
Page 211 of 422
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838104
Page 212 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838105
Page 213 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838106
Page 214 of 422
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Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838107
Page 215 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838108
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838109
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Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838110
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Unscheduled Visit on Dec/10/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-14-2020 09:06:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838111
Page 219 of 422
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Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:06:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838112
Page 220 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:06:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
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FDA-CBER-2021-5683-0838113
Page 221 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:06:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0838114
Page 222 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:06:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838115
Page 223 of 422
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:06:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838116
Page 224 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:06:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838117
Page 225 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:06:54 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838118
Page 226 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:06:54 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838119
Page 227 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:06:54 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838120
Page 228 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:07:04 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838121
Page 229 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:07:04 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838122
Page 230 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:07:04 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838123
Page 231 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:07:04 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838124
Page 232 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:22:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838125
Page 233 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:22:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838126
Page 234 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:22:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838127
Page 235 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:22:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838128
Page 236 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 09:22:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838129
Page 237 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-14-2020 09:22:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838130
Page 238 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-14-2020 09:22:13 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838131
Page 239 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 09:22:31 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838132
Page 240 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 09:22:31 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838133
Page 241 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 09:22:31 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838134
Page 242 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 09:22:31 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838135
Page 243 of 422
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/10/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 09:22:31 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838136
Page 244 of 422
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION -
Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-03-2021 14:34:12 (UTC-08:00)
Pacific Time (US & Canada)Could you please unfreeze subject
12641006? He meets eligibility
criteria and since has been
revaccinated
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838137
Page 245 of 422
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-29-2021 11:47:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838138
Page 246 of 422
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Albertson Approved Mar-11-2021 14:48:33 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyAlbertson, 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-28-2021 08:58:08 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Albertson Approved Jan-22-2021 16:48:13 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838139
Page 247 of 422
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, TimothyAlbertson, 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.
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838140
Page 248 of 422
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-28-2020
08:52:22
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-28-2020
08:52:22
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838141
Page 249 of 422
***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, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-29-2020
08:48:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Oct/27/2020Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838142
Page 250 of 422
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-28-2020
08:52:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12641229Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-28-2020
08:52:03
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1958Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-30-2020
01:59:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-29-2020
08:48:09
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838143
Page 251 of 422
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
Oct-29-2020
08:48:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
Oct-28-2020
23:51:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Sex,Ethnicity
and Race" is
missing. Kindly
review and
update.
4. Ethnicity:
Date Location User Value Reason
Oct-29-2020
08:48:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-29-2020
08:48:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838144
Page 252 of 422
***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, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020
23:57:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-30-2020
12:21:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dThis has been
completed.
Thank you.
Oct-29-2020
06:19:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
review and
complete ‘HIV
status, Medical
History,
Reactogenicity
Diary,
Vaccination,
Randomization,
Vital Signs'
forms at this
visit. Thank
you.
Oct-28-2020
08:53:48
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
Oct/27/2020Transcription
Error
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838145
Page 253 of 422
***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, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
Oct-28-2020
08:53:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838146
Page 254 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-28-2020
08:54:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020
08:54:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020
08:54:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838147
Page 255 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-29-2020
08:49:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-29-2020
08:49:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020
08:49:26
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838148
Page 256 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
1.a Start Date:
Date Location User Value Reason
Oct-29-2020
08:49:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-29-2020
08:49:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-29-2020
08:50:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:ACL repai
r, left
Start Date
:UNK/UN
K/1990Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838149
Page 257 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: NO
End Date
:
UNK/U
NK/199
0
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838150
Page 258 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Oct-29-2020
08:50:04
(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
Oct-29-2020
08:50:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ACL repair, leftInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-29-2020
08:50:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-29-2020
08:50:04ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838151
Page 259 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/1990
1.c
Date Location User Value Reason
Oct-29-2020
08:50:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Meniscus te
ar repair, lef
t
Start Dat
e:UNK/UNK/
1990
Ongoing: NO
End Date:
UNK/U
NK/199
0Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838152
Page 260 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Oct-29-2020
08:50:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020
08:50:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Meniscus tear repair,
leftInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-29-2020
08:50:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-29-2020
08:50:33ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838153
Page 261 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/1990
1.d
Date Location User Value Reason
Oct-29-2020
08:51:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Meniscus te
ar repair, rig
ht
Start Dat
e:UNK/UNK/
2016
Ongoing: NO
End Date:
UNK/U
NK/2016Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838154
Page 262 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Oct-29-2020
08:51:01
(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
Oct-29-2020
08:51:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Meniscus tear repair,
rightInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-29-2020
08:51:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-29-2020
08:51:01ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838155
Page 263 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2016
1.e
Date Location User Value Reason
Oct-29-2020
08:51:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Lupus
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838156
Page 264 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Oct-29-2020
08:51:38
(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
Oct-30-2020
09:51:05
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-29-2020
15:02:28
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answe
redNo, the subject
reported that they
are managing their
lupus symptoms
without medication.
Oct-29-2020
12:34:40
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dClinQuery: Is
subject receiving
treatment with
immunosuppressive
therapy, including
cytotoxic agents or
systemic
corticosteroids for
Lupus?
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838157
Page 265 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-29-2020
08:51:38
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LupusInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-29-2020
08:51:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-29-2020
08:51:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-29-2020
08:51:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838158
Page 266 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical H
istory Ter
m:Vasectomy
Start Date
:UNK/UN
K/1991
Ongoing: NO
End Date
:
UNK/U
NK/199
1
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838159
Page 267 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Oct-29-2020
08:51:56
(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
Oct-29-2020
08:51:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VasectomyInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-29-2020
08:51:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1991Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-29-2020
08:51:56ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838160
Page 268 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/1991
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838161
Page 269 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-29-2020
08:49:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT k
nown to be HIV POS
ITIVEInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838162
Page 270 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838163
Page 271 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
168.7Initial Entry
5. Unit:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34.3Initial Entry
7.a
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.3Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838164
Page 272 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838165
Page 273 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a Temperature Location:
Date Location User Value Reason
Oct-29-2020
08:54:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838166
Page 274 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-30-2020
12:21:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-30-2020
12:21:19
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
273378Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838167
Page 275 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
08:54:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
08:54:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
08:54:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
08:54:33
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838168
Page 276 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-28-2020
08:54:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020
08:54:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRSSB7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020
08:54:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRSSB7Initial Entry
5.b
Date Location User Value Reason
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838169
Page 277 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-28-2020
08:55:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRSSB8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020
08:55:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRSSB8Initial Entry
5.c
Date Location User Value Reason
Oct-28-2020
08:55:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM930
WInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020
08:55:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM930WInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838170
Page 278 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
08:55:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
08:55:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
08:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
08:55:21
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838171
Page 279 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-28-2020
08:55:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020
08:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM930VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020
08:55:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM930VInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838172
Page 280 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838173
Page 281 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020 14:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838174
Page 282 of 422
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-29-2020
08:55:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838175
Page 283 of 422
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-29-2020
08:55:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838176
Page 284 of 422
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020
12:08:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/16/2020Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838177
Page 285 of 422
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Nov-16-2020
12:09:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/16/2020Initial Entry
2.a
Date Location User Value Reason
Nov-16-2020
12:09:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.0
Temperatur
e Unit:C
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-16-2020
12:09:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838178
Page 286 of 422
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Temperature:
Date Location User Value Reason
Nov-17-2020
00:11:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-16-2020
12:34:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dPer PI, NCS
Nov-16-2020
12:09:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature
36 C is outside
of Normal
Range 36.1 -
37.5 C.
Nov-16-2020
12:09:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.0Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-16-2020
12:09:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838179
Page 287 of 422
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Temperature Location:
Date Location User Value Reason
Nov-16-2020
12:09:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3007\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838180
Page 288 of 422
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641229 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-16-2020
10:54:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-16-2020
10:54:44
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-16-2020
10:54:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Que
…[truncated]