Document text
Page 1 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837640
Page 2 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
Sep/22/2020
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837641
Page 3 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12641195]
2.Birth Date: /1946
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837642
Page 4 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837643
Page 5 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837644
Page 6 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837645
Page 7 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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:[Eczema]
Start Date: Mar/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1950
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Meningioma (asymptomatic, stable, no treatment plans)]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitiligo]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837646
Page 8 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:["Pre-diabetes" elevated HgbA1C]
Start Date: UNK/UNK/2011
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Latex allergy]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sulfa allergy (hives)]
Start Date: UNK/UNK/1980
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal allergies (molds and spores)]
Start Date: UNK/UNK/1950
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837647
Page 9 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin allergy (hives)]
Start Date: UNK/UNK/2000
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Amoxicillin allergy (hives)]
Start Date: UNK/UNK/2000
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inner ear pain 14d post shingles vaccine]
Start Date: Nov/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2015
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tubal ligation]
Start Date: UNK/UNK/1974
Ongoing: NO
End Date:
UNK/UNK/1974
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837648
Page 10 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Skin biopsy (benign)]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast biopsy (benign)]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prednisone taper ]
Start Date: Nov/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2015
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acupuncture]
Start Date: Nov/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2015
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837649
Page 11 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tinnitus 14d post shingles vaccine]
Start Date: Nov/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2015
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vertigo 14d post shingles vaccine]
Start Date: Nov/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2015
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837650
Page 12 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837651
Page 13 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [102.2]
3.Unit: kg
4.Height: [167.5]
5.Unit: cm
6.Body Mass Index: [36.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: FOREHEAD
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837652
Page 14 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837653
Page 15 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [264013]
3.Randomization Group: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837654
Page 16 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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:
Sep/22/2020
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 [BM92PN]
5.bSample ID [BNWC66]
5.cSample ID [BNWC67]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837655
Page 17 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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:
Sep/22/2020
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 [BM92PJ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837656
Page 18 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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: Sep/22/2020 14:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837657
Page 19 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837658
Page 20 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837659
Page 21 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: FOREHEAD
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837660
Page 22 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837661
Page 23 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM92W6]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837662
Page 24 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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?YES
Date of First Delay:
Oct/14/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location:
6.Body Side: Not Applicable Comments
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?Not Applicable Comments
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837663
Page 25 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837664
Page 26 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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:
Nov/13/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM92D6]
5.bSample ID [BRSSHW]
5.cSample ID [BRSSHX]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837665
Page 27 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837666
Page 28 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837667
Page 29 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837668
Page 30 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837669
Page 31 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837670
Page 32 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837671
Page 33 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837672
Page 34 of 254
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837673
Page 35 of 254
***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: 12641195 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:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837674
Page 36 of 254
***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: 12641195 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 [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837675
Page 37 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: 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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837676
Page 38 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED VISIT
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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837677
Page 39 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: CONTACT OUTCOME - UNPLANNED
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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/24/2021
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837678
Page 40 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Feb/24/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837679
Page 41 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Feb/24/2021
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: NO
4.bReaction: SWELLING
Reaction Present: NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: NO
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
5.cSymptom: HEADACHE
Symptom Present: NO
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: NO
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837680
Page 42 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
5 hSymptom: CHILLS
Symptom Present: NO
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837681
Page 43 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Cheilitis Oct/7/2020 UNK
:UNK NO
End Date Time:
Nov/9/2020 UNK:UNK
Repeating
Pages
2.ADVERSE E
VENT 2 Dry mouth Oct/7/2020 UNK
:UNK YES Repeating
Pages
3.ADVERSE E
VENT 3 Pruritus, abdomen Oct/7/2020 UNK
:UNK YES Repeating
Pages
4.ADVERSE E
VENT 4 Rash maculo-papular,
abdomen Oct/7/2020 UNK
:UNK YES Repeating
Pages
5.ADVERSE E
VENT 5 Hyperosmia Oct/7/2020 UNK
:UNK NO
End Date Time:
Nov/13/2020 UNK:UN
K
Repeating
Pages
6.ADVERSE E
VENT 6 Worsening eczema Oct/7/2020 UNK
:UNK YES Repeating
Pages
7.ADVERSE E
VENT 7 Dysgeusia Oct/7/2020 UNK
:UNK NO
End Date Time:
Nov/13/2020 UNK:UN
K
Repeating
Pages
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837682
Page 44 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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)[Cheilitis]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837683
Page 45 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837684
Page 46 of 254
***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: 12641195 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dry mouth]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837685
Page 47 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837686
Page 48 of 254
***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: 12641195 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pruritus, abdomen]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837687
Page 49 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837688
Page 50 of 254
***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: 12641195 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Rash maculo-papular, abdomen]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837689
Page 51 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837690
Page 52 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hyperosmia]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/13/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837691
Page 53 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837692
Page 54 of 254
***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: 12641195 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening eczema]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837693
Page 55 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837694
Page 56 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dysgeusia]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/13/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837695
Page 57 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837696
Page 58 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837697
Page 59 of 254
***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: 12641195 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[ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837698
Page 60 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837699
Page 61 of 254
***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: 12641195 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: //
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837700
Page 62 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837701
Page 63 of 254
***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: 12641195 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?
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837702
Page 64 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837703
Page 65 of 254
***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: 12641195 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?
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837704
Page 66 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837705
Page 67 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837706
Page 68 of 254
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837707
Page 69 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837708
Page 70 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837709
Page 71 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837710
Page 72 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12641195 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?
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837711
Page 73 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837712
Page 74 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837713
Page 75 of 254
***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: 12641195 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: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837714
Page 76 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/30/2021
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837715
Page 77 of 254
***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: 12641195 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 1/2
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837716
Page 78 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/30/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837717
Page 79 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837718
Page 80 of 254
***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: 12641195 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: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837719
Page 81 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837720
Page 82 of 254
***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: 12641195 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
Mar/3/2021
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837721
Page 83 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837722
Page 84 of 254
***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: 12641195 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
:Mar/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837723
Page 85 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/3/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837724
Page 86 of 254
***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: 12641195 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:
Feb/24/2021
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 [BR4FBV]
5.bSample ID [BSGR87]
5.cSample ID [BSGR88]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837725
Page 87 of 254
***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: 12641195 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/24/2021
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 [BRFHBG]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837726
Page 88 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO Comments
2.Treatment Name [BNT162b2] Comments
3.Formulation: INJECTION Comments
4.Dose Date Time: Mar/3/2021 10:14 Comments
5.Anatomical Location: DELTOID MUSCLE Comments
6.Body Side: LEFT Comments
7.Route: INTRAMUSCULAR Comments
8.Actual Dose: [30.0] Comments
9.Unit: ug Comments
10.Timeframe Subject Was Observed 30 MINUTES Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES Comments
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837727
Page 89 of 254
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837728
Page 90 of 254
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837729
Page 91 of 254
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837730
Page 92 of 254
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 12641195 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?
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837731
Page 93 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837732
Page 94 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837733
Page 95 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837734
Page 96 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837735
Page 97 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837736
Page 98 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837737
Page 99 of 254
***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: 12641195 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: [ ]
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837738
Page 100 of 254
***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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/14/2020
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837739
Page 101 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837740
Page 102 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 14:42:59 (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.
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837741
Page 103 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-23-2020 13:39:30 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837742
Page 104 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-16-2020 08:43:41 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837743
Page 105 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-16-2020 08:43:49 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837744
Page 106 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Oct-16-2020 08:43:56 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837745
Page 107 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormMar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
FormMar-08-2021 13:58:04 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
FormMar-08-2021 11:49:19 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because there was a transcription error. Thank
you!
FormMar-03-2021 12:28:32 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 because there was
a transcription error. Thank you!
FormFeb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101
but because of a presumed reaction to her V1
dose, she was not dosed for V2 therefor drug
was unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837746
Page 108 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
1Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837747
Page 109 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
2Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837748
Page 110 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
3Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837749
Page 111 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
4Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837750
Page 112 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
5Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837751
Page 113 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
6Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837752
Page 114 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
7Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837753
Page 115 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
8Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837754
Page 116 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
9Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837755
Page 117 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
10Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837756
Page 118 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Mar-10-2021 13:23:37 (UTC-08:00) Pacific
Time (US & Canada)Please unfreeze V101VAX3 VACCINE TRT
because I need to enter data. It is not allowing
me to change the data.
11Feb-24-2021 15:52:10 (UTC-08:00) Pacific
Time (US & Canada)Subject was eligible for vaccination at V101 but
because of a presumed reaction to her V1 dose,
she was not dosed for V2 therefor drug was
unable to be dispensed for V101 with an
incomplete V2. Subject is rescheduled for
Vaccination on 26February2021.
Not Done
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837757
Page 119 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 14:42:59 (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 Feb-09-2021 12:46:40 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Albertson Approved Jan-22-2021 16:30:25 (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 Dec-03-2020 09:45:17 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837758
Page 120 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Timothy
Albertson Approved Nov-16-2020 18:03:57 (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 Nov-13-2020 14:26:15 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Albertson Approved Nov-13-2020 14:07:59 (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 Nov-13-2020 09:45:57 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Albertson Approved Nov-11-2020 15:59:40 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837759
Page 121 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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.
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837760
Page 122 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
Sep-23-2020 13:36:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-23-2020 13:36:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837761
Page 123 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020 13:37:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/22/2020Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837762
Page 124 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-23-2020 13:36:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12641195Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-23-2020 13:36:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020 13:39:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-23-2020 13:39:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-23-2020 13:39:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERI
CANInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837763
Page 125 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 09:12:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-25-2020 08:51:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Sep-24-2020 13:36:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
update
Randomization page
Sep-23-2020 13:39:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837764
Page 126 of 254
***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, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
Sep-23-2020 13:40:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 13:40:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 13:40:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837765
Page 127 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-23-2020 13:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Eczema
Start Date: Mar/UNK/2
018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:40:33
(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
Sep-23-2020 13:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EczemaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-23-2020 13:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-23-2020 13:40:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837766
Page 128 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b
Date Location User Value Reason
Sep-23-2020 13:40:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Asthma
Start Date: UNK/UNK/1
950
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:40:53
(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
Sep-23-2020 13:40:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-23-2020 13:40:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1950Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020 13:40:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837767
Page 129 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-23-2020 13:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Meningioma (asympto
matic, stable, no treat
ment plans)
Start Dat
e:UNK/UNK/2015
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:41:29
(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
Sep-23-2020 13:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Meningioma (asymptomatic, stab
le, no treatment plans)Initial Entry
1.c Start Date:
Date Location User Value Reason
Sep-23-2020 13:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-23-2020 13:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837768
Page 130 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-23-2020 13:41:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Vitiligo
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:41:42
(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
Sep-23-2020 13:41:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VitiligoInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-23-2020 13:41:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-23-2020 13:41:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-23-2020 13:42:17
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837769
Page 131 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) Line/MH Nu
mber:5
Medical Hist
ory Term:"Pre-diabetes" ele
vated HgbA1C
Start Date: UNK/UNK/2011
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:42:17
(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
Sep-23-2020 13:42:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
"Pre-diabetes" elevated HgbA1CInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-23-2020 13:42:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-23-2020 13:42:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-24-2020 09:52:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:6Transcription Error
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837770
Page 132 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical History
Term:Latex allerg
y
Start Date: UNK/UNK/
2010
Ongoing: YES
Sep-23-2020 13:42:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:Latex allergy (
welts, rash)
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837771
Page 133 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:42:40
(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
Sep-24-2020
13:46:09
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clos
edDiscrepancy
has been
closed.
Sep-24-2020
09:52:03
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Sep-24-2020
09:52:03
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Latex allergyTranscription
Error
Sep-23-2020
20:01:33
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Ope
nedMultiple
concepts in the
term LATEX
ALLERGY
(WELTS,
RASH). Split
the term into
LATEX
ALLERGY
and
ALLERGIC
WELTS,
RASH and
submit
separately.
Thank you.
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837772
Page 134 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-23-2020
13:42:40
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Latex allergy (
welts, rash)Initial Entry
1.f Start Date:
Date Location User Value Reason
Sep-23-2020 13:42:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-23-2020 13:42:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-23-2020 13:42:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Sulfa allergy (
hives)
Start Date: UNK/UNK/19
80
Ongoing: YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837773
Page 135 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.g Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:42:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:42:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sulfa allergy (hives)Initial Entry
1.g Start Date:
Date Location User Value Reason
Sep-23-2020 13:42:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-23-2020 13:42:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-23-2020 13:43:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Seasonal allergies (
molds and spores)
Start Date: UNK/UNK/1950
Ongoing: YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837774
Page 136 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:43:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:43:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal allergies (molds and spo
res)Initial Entry
1.h Start Date:
Date Location User Value Reason
Sep-23-2020 13:43:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1950Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-23-2020 13:43:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-23-2020 13:43:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:Osteoarthritis
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837775
Page 137 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.i Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:43:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:43:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OsteoarthritisInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-23-2020 13:43:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-23-2020 13:43:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837776
Page 138 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.j
Date Location User Value Reason
Sep-23-2020 13:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:Penicillin allerg
y (hives)
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Penicillin allergy (hives)Initial Entry
1.j Start Date:
Date Location User Value Reason
Sep-23-2020 13:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-23-2020 13:44:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837777
Page 139 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.k
Date Location User Value Reason
Sep-23-2020 13:44:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histo
ry Term:Amoxicillin aller
gy (hives)
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:44:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:44:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Amoxicillin allergy (hives)Initial Entry
1.k Start Date:
Date Location User Value Reason
Sep-23-2020 13:44:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-23-2020 13:44:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837778
Page 140 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-25-2020 08:52:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:12
Medical H
istory Ter
m:Inner ear pain 14d
post shingles vacci
ne
Start Date
:Nov/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2015Transcription Error
Sep-24-2020 09:57:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/M
H Numb
er:12
Medical
History
Term:Inner ear pain, tinnitu
s, vertigo 14d post sh
ingles vaccine
Start Da
te:Nov/UNK/2015
Ongoing
:NO
End Date:
Dec/UNK/2015Transcription Error
Sep-23-2020 13:46:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umbe
r:12
Medic
al His
tory T
erm:Inner ear pain, tinnitus,
vertigo 14d post shingle
s vaccine resolved w pre
dnisone taper, acupunct
ure
Start
Date:Nov/UNK/2015Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837779
Page 141 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoi
ng:NO
End Date:
Dec/UNK/2015
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837780
Page 142 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.l Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:46:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020
09:22:54
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: C
losedDiscrepancy has
been closed.
Sep-25-2020
08:52:38
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: A
nsweredTranscription Error
Sep-25-2020
08:52:38
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Inner ear p
ain 14d po
st shingles
vaccineTranscription Error
Sep-24-2020
17:28:53
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: O
penedMultiple concepts
in the term INNER
EAR PAIN,
TINNITUS,
VERTIGO 14D
POST SHINGLES
VACCINE. Split
the term into
INNER EAR PAIN
and TINNITUS
and VERTIGO
14D POST
SHINGLES
VACCINE and
report as 3 separate
entries. Thank you.
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837781
Page 143 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-24-2020
13:46:22
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: C
losedDiscrepancy has
been closed.
Sep-24-2020
09:57:07
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredTranscription Error
Sep-24-2020
09:57:07
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Inner ear p
ain, tinnitu
s, vertigo 1
4d post shi
ngles vacci
neTranscription Error
Sep-24-2020
01:47:17
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: O
penedMultiple actions
for INNER EAR
PAIN, TINNITUS,
VERTIGO 14D
POST SHINGLES
VACCINE
RESOLVED W
PREDNISONE
TAPER,
ACUPUNCTURE:
Please split the
term into INNER
EAR PAIN,
TINNITUS,
VERTIGO 14D
POST SHINGLES
VACCINE and
PREDNISONE
TAPER and
ACUPUNCTURE
and submit as three
separate entries.
Also move
PREDNISONE
TAPER to the drug
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837782
Page 144 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
page. Thank you.
Sep-23-2020
13:46:51
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Inner ear p
ain, tinnitu
s, vertigo 1
4d post shi
ngles vacci
ne resolved
w predniso
ne taper, ac
upunctureInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-23-2020 13:46:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-23-2020 13:46:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2015Initial Entry
1.m
Date Location User Value Reason
Sep-23-2020 13:47:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:13
Medical History
Term:Tubal ligation
Start Date: UNK/UNK/19
74Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837783
Page 145 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: NO
End Date:
UNK/UNK/
1974
1.m Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:47:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:47:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Tubal ligationInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-23-2020 13:47:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1974Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-23-2020 13:47:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1974Initial Entry
1.n
Date Location User Value Reason
Sep-23-2020 13:47:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 14Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837784
Page 146 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
er:
Medical History
Term:Skin biopsy (be
nign)
Start Date: UNK/UNK/19
85
Ongoing: NO
End Date:
UNK/UNK/
1985
1.n Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:47:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:47:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Skin biopsy (benign)Initial Entry
1.n Start Date:
Date Location User Value Reason
Sep-23-2020 13:47:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-23-2020 13:47:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1985Initial Entry
1.o
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837785
Page 147 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-23-2020 13:48:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:15
Medical Histor
y Term:Breast biopsy (b
enign)
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837786
Page 148 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.o Line/MH Number:
Date Location User Value Reason
Sep-23-2020 13:48:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 13:48:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Breast biopsy (benign)Initial Entry
1.o Start Date:
Date Location User Value Reason
Sep-23-2020 13:48:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-23-2020 13:48:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.p
Date Location User Value Reason
Sep-25-2020 08:56:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:16
Medical Histor
y Term:Prednisone ta
per
Start Date: Nov/UNK/20
15Transcription Error
(DELETED)
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837787
Page 149 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: NO
End Date:
Dec/UNK/
2015
Sep-24-2020 09:58:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:16
Medical Histor
y Term:Prednisone ta
per
Start Date: Nov/UNK/20
15
Ongoing: NO
End Date:
Dec/UNK/
2015Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837788
Page 150 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.p Line/MH Number:
Date Location User Value Reason
Sep-25-2020 08:56:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
16Transcription Error
(DELETED)
Sep-24-2020 09:58:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-28-2020
05:35:57
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse
satisfies query
Sep-25-2020
08:56:38
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Predni
sone t
aperTranscription
Error
(DELETED)
Sep-25-2020
08:56:38
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: Ans
weredTranscription
Error
Sep-24-2020
13:58:39
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Op
enedClarify
PREDNISONE
TAPER as
follows...Drug
only reported.
Are you
reporting
ALLERGY TO?
INTERACTION
WITH? Other?
Please update
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837789
Page 151 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
the verbatim
term to clarify.
If reporting
therapeutic use,
please move the
term to the drug
page. Thank
you.
Sep-24-2020
09:58:32
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Predni
sone t
aperInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-25-2020 08:56:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Transcription Error
(DELETED)
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837790
Page 152 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.p Start Date:
Date Location User Value Reason
Sep-24-2020 09:58:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-25-2020 08:56:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2015Transcription Error
(DELETED)
Sep-24-2020 09:58:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2015Initial Entry
1.q
Date Location User Value Reason
Sep-24-2020 09:58:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:17
Medical History
Term:Acupuncture
Start Date: Nov/UNK/201
5
Ongoing: NO
End Date:
Dec/UNK/2
015Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837791
Page 153 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.q Line/MH Number:
Date Location User Value Reason
Sep-24-2020 09:58:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-24-2020 09:58:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AcupunctureInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-24-2020 09:58:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-24-2020 09:58:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2015Initial Entry
1.r
Date Location User Value Reason
Sep-25-2020 08:53:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:18
Medical Hist
ory Term:Tinnitus 14d post s
hingles vaccine
Start Date: Nov/UNK/2015Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837792
Page 154 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: NO
End Date:
Dec/UNK/2015
1.r Line/MH Number:
Date Location User Value Reason
Sep-25-2020 08:53:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 08:53:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Tinnitus 14d post shingles vaccin
eInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-25-2020 08:53:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-25-2020 08:53:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2015Initial Entry
1.s
Date Location User Value Reason
Sep-25-2020 08:54:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:19Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837793
Page 155 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical Hist
ory Term:Vertigo 14d post sh
ingles vaccine
Start Date: Nov/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2015
1.s Line/MH Number:
Date Location User Value Reason
Sep-25-2020 08:54:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 08:54:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Vertigo 14d post shingles vaccineInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-25-2020 08:54:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2015Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-25-2020 08:54:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2015Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837794
Page 156 of 254
***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, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
Sep-23-2020 13:48:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837795
Page 157 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
102.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
167.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-23-2020 13:49:12 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837796
Page 158 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) 36.4
7.a
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.3
Temperature Unit: C
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 13:49:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837797
Page 159 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837798
Page 160 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-23-2020 13:49:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837799
Page 161 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-25-2020 08:51:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-25-2020 08:51:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
264013Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837800
Page 162 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 11:14:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 11:14:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 11:14:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 11:14:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 11:14:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 11:14:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM92PNInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837801
Page 163 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 11:14:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM92PNInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020 11:14:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWC66Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-24-2020 11:14:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWC66Initial Entry
5.c
Date Location User Value Reason
Sep-24-2020 11:14:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWC67Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-24-2020 11:14:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWC67Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837802
Page 164 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 08:03:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 08:03:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 08:03:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 08:03:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 08:03:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 08:03:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM92PJInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837803
Page 165 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 08:03:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM92PJInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837804
Page 166 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020 14:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020 13:49:46 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837805
Page 167 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-23-2020 13:49:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837806
Page 168 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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
Sep-23-2020 13:49:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837807
Page 169 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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-15-2020 08:59:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837808
Page 170 of 254
***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, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 08:41:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2.a
Date Location User Value Reason
Oct-16-2020 08:41:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 08:41:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-16-2020 08:41:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-16-2020 08:41:44
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837809
Page 171 of 254
***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, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 08:41:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837810
Page 172 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837811
Page 173 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-16-2020 08:41:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837812
Page 174 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 08:59:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 08:59:14
(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-15-2020 08:59:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 08:59:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 08:59:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 08:59:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM92W6Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837813
Page 175 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 08:59:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM92W6Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837814
Page 176 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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-16-2020 08:43:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Oct/14/2020
Reason(s) for Temporary Delay
of Vaccination
FEVER OR ACUTE ILLNES
SInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Oct-29-2020
04:22:39
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Del
etedDelay in vaccination
Oct-18-2020
23:22:13
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ca
ndidat
eDMW5057796;Dose
Date is not expected
to be Unknown or
Not Applicable.
Please review and
update appropriately
or clarify
Oct-18-2020
23:21:52
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedNeed to keep in
Candidate
Oct-18-2020
23:18:56
(UTC-08:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5057796;Dose
Date is not expected
to be Unknown or
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837815
Page 177 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time
(US &
Canada)Not Applicable.
Please review and
update appropriately
or clarify
Oct-16-2020
08:43:41
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020 08:43:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-16-2020 08:43:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837816
Page 178 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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-13-2020 09:45:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837817
Page 179 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 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 08:38:07
(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 08:38:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-16-2020 08:38:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-16-2020 08:38:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-16-2020 08:38:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-16-2020 08:38:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM92D6Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837818
Page 180 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Nov-16-2020 08:38:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM92D6Initial Entry
5.b
Date Location User Value Reason
Nov-16-2020 08:38:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRSSHWInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-16-2020 08:38:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRSSHWInitial Entry
5.c
Date Location User Value Reason
Nov-16-2020 08:38:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRSSHXInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-16-2020 08:38:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRSSHXInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837819
Page 181 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: 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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 12:29:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837820
Page 182 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED VISIT - 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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Assessments
Date Location User Value Reason
Mar-03-2021 12:31:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 12:30:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form
is not entered.
Please review and
update as
appropriate.
Mar-03-2021 12:30:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837821
Page 183 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: CONTACT OUTCOME - UNPLANNED - 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: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-03-2021 12:31:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 12:31:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Contact Outcome' is
selected as 'VISIT
ARRANGED' but
no 'VITAL SIGNS'
and/or
'UNPLANNED
ASSESSMENT OF
LOCAL
REACTION'
form(s) is/are
entered. Please
review and update
as appropriate.
Mar-03-2021 12:31:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/24/2021
Contact Outcome:
VISIT ARRANGEDInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837822
Page 184 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Mar-03-2021 12:33:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-03-2021 12:33:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-03-2021 12:33:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/24/2021Transcription Error
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Vital Signs Date is
not equal to Date of
Assessment for the
Unplanned
Assessment of
Local Reaction at
the same unplanned
visit. Please review
and correct as
appropriate or
clarify.
Mar-03-2021 12:31:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Collection Date,
24/Mar/2021 is a
future date relative
to when it was
entered on 03/Mar
/2021. Please
correct.
Mar-03-2021 12:31:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/24/2021Initial Entry
2.a
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837823
Page 185 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-03-2021 12:31:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Mar-03-2021 12:31:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Mar-03-2021 12:31:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Mar-03-2021 12:31:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Mar-03-2021 12:31:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837824
Page 186 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
2. Injection Site Location
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
Mar-03-2021 12:33:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
4.a
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: REDNESS
Reaction Present:: NOInitial Entry
4.a Reaction:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
4.a Reaction Present:
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837825
Page 187 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: SWELLIN
G
Reaction Present:
:NOInitial Entry
4.b Reaction:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: PAIN AT INJECT
ION SITE
Symptom Pr
esent::NOInitial Entry
5.a Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837826
Page 188 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
5.a Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FATIGUE/TIRE
DNESS
Symptom Pre
sent::NOInitial Entry
5.b Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUE/TIREDNESSInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEADACH
E
Symptom Present
::NOInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837827
Page 189 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.d
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VOMITIN
G
Symptom Present:
:NOInitial Entry
5.d Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.e
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837828
Page 190 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIARRHE
A
Symptom Present
::NOInitial Entry
5.e Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.f
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
::NEW OR WORSEN
ED MUSCLE PAIN
Symptom
Present::NOInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837829
Page 191 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.f Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.g
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:NEW OR WORSE
NED JOINT PAIN
Symptom
Present::NOInitial Entry
5.g Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.h
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837830
Page 192 of 254
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/24/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:13 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CHILLS
Symptom Present:: NOInitial Entry
5.h Symptom:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Mar-03-2021 12:32:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837831
Page 193 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837832
Page 194 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837833
Page 195 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-30-2020 15:27:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837834
Page 196 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-30-2020 15:28:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837835
Page 197 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-04-2020 11:18:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837836
Page 198 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-04-2020 11:20:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837837
Page 199 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-04-2020 11:21:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837838
Page 200 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CheilitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 14:27:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/9/2020 UNK:UNKNew Information
Nov-10-2020 09:18:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837839
Page 201 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-09-2020 13:08:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Per last contact
w/subject event is
ongoing.
Nov-09-2020 12:37:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
advise if this event
is still ongoing?
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837840
Page 202 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-13-2020 14:27:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-13-2020 14:27:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-13-2020 14:27:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Cheilitis:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837841
Page 203 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
present.
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-30-2020 15:22:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837842
Page 204 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dry mouthInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020 09:18:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-09-2020 13:08:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Per last contact
w/subject event is
ongoing.
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837843
Page 205 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-09-2020 12:38:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
advise if this event
is still ongoing?
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837844
Page 206 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641195 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-03-2020 09:48:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNQuery resolution.
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-30-2020 15:25:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae300a\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837845
Page 207 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled For
…[truncated]