Document text
Page 1 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838647
Page 2 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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/21/2020
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838648
Page 3 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12651149]
2.Birth Date: /1970
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:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838649
Page 4 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838650
Page 5 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838651
Page 6 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838652
Page 7 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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:[Back surgery]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparoscopic Hysterectomy]
Start Date: Dec/7/2018
Ongoing: NO
End Date:
Dec/7/2018
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparoscopic Salpingectomy]
Start Date: Dec/7/2018
Ongoing: NO
End Date:
Dec/7/2018
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838653
Page 8 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cystoscopy]
Start Date: Dec/7/2018
Ongoing: NO
End Date:
Dec/7/2018
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension (Chronic)]
Start Date: Dec/11/2017
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: Dec/11/2017
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iron Deficiency Anemia]
Start Date: Apr/4/2018
Ongoing: YES
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838654
Page 9 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Low Back Pain]
Start Date: Apr/4/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Reactive Airway Disease (Chronic)]
Start Date: Apr/7/2019
Ongoing: YES
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838655
Page 10 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838656
Page 11 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
2.Weight: [122.9]
3.Unit: kg
4.Height: [170.7]
5.Unit: cm
6.Body Mass Index: [42.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838657
Page 12 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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/21/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838658
Page 13 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/21/2020
2.Randomization Number: [94345]
3.Randomization Group: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838659
Page 14 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP959X]
5.bSample ID [BP959Y]
5.cSample ID [BP959Z]
5.dSample ID [BMNMRS]
5.eSample ID [BMNMRT]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838660
Page 15 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP95B0]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838661
Page 16 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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/21/2020 11:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838662
Page 17 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838663
Page 18 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838664
Page 19 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838665
Page 20 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838666
Page 21 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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/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 [BPY452]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838667
Page 22 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/13/2020 10:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838668
Page 23 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838669
Page 24 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9YXG]
5.bSample ID [BS68H6]
5.cSample ID [BS68H7]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838670
Page 25 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838671
Page 26 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838672
Page 27 of 155
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838673
Page 28 of 155
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838674
Page 29 of 155
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838675
Page 30 of 155
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838676
Page 31 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838677
Page 32 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838678
Page 33 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838679
Page 34 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838680
Page 35 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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?
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838681
Page 36 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838682
Page 37 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838683
Page 38 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838684
Page 39 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838685
Page 40 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838686
Page 41 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838687
Page 42 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838688
Page 43 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Sore and swollen underarm
lymph node (both arms) Oct/14/2020
UNK:UNK NO
End Date Time:
Oct/15/2020 UN
K:UNK
Repeating
Pages
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838689
Page 44 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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)[Sore and swollen underarm lymph node (both arms)]
4.Start Date Time: Oct/14/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/15/2020 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
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838690
Page 45 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838691
Page 46 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838692
Page 47 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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[ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838693
Page 48 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of MedicationStart
DateForm Instan
ce
1.1 VACCINATI
ONS NO Flulaval Quadrivalent I
nfluenza Vaccination Nov/16
/2020 Repeating
Pages
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838694
Page 49 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown,
enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Flulaval Quadrivalent Influenza Vaccination]
5.Date: Nov/16/2020
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838695
Page 50 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838696
Page 51 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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?
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838697
Page 52 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838698
Page 53 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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?
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838699
Page 54 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838700
Page 55 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838701
Page 56 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838702
Page 57 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838703
Page 58 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838704
Page 59 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838705
Page 60 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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?
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838706
Page 61 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838707
Page 62 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838708
Page 63 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838709
Page 64 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838710
Page 65 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838711
Page 66 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838712
Page 67 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838713
Page 68 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838714
Page 69 of 155
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838715
Page 70 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838716
Page 71 of 155
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838717
Page 72 of 155
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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: [ ]
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838718
Page 73 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/16/2020
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838719
Page 74 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838720
Page 75 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
William
Towner Approved Mar-09-2021 20:34:04 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, 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.
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838721
Page 76 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-21-2020 13:11:59 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838722
Page 77 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-13-2020 11:01:06 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential. Patient's last date of menstrual
was in 2017.
FormOct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838723
Page 78 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838724
Page 79 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838725
Page 80 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838726
Page 81 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838727
Page 82 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838728
Page 83 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838729
Page 84 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838730
Page 85 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-13-2020 11:00:49 (UTC-08:00)
Pacific Time (US & Canada)Patient is not a female of childbearing
potential Patient's last date of menstrual
was in 2017.
Not Done
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0838731
Page 86 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
William
Towner Approved Mar-09-2021 20:34:04 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-28-2021 17:10:19 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Towner Approved Jan-20-2021 18:55:06 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, 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.
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838732
Page 87 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
N/A Nov-18-2020 16:49:23 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Towner Approved Nov-17-2020 15:47:15 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, 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-16-2020 11:44:58 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Towner Approved Nov-02-2020 12:02:21 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamTowner, 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.
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838733
Page 88 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-21-2020
13:10:28
(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-21-2020
13:10:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838734
Page 89 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-21-2020
13:11:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Ob
tained
Sep/21/2020Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838735
Page 90 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-21-2020 13:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12651149Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-21-2020 13:10:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-21-2020
13:11:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-21-2020
13:11:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH
ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-21-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838736
Page 91 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13:11:35
(UTC-08:00) Pacific
Time (US & Canada)BLACK OR AFRICAN A
MERICAN
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838737
Page 92 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-21-2020
13:11:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838738
Page 93 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-21-2020
13:12:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-21-2020 13:12:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-21-2020
13:12:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838739
Page 94 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-21-2020 13:13:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Back surgery
Start Date: UNK/UNK/
2009
Ongoing: NO
End Date:
UNK/UN
K/2009Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:13:47
(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-21-2020
13:13:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Back surgeryInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838740
Page 95 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-21-2020
13:13:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-21-2020
13:13:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.b
Date Location User Value Reason
Sep-21-2020 13:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term
:Laparoscopic
Hysterectomy
Start Date: Dec/7/2018
Ongoing: NO
End Date:
Dec/7/2018Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838741
Page 96 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020
13:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Laparoscopic Hysterectom
yInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-21-2020
13:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-21-2020
13:15:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/7/2018Initial Entry
1.c
Date Location User Value Reason
Sep-21-2020 13:16:38 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838742
Page 97 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) Line/MH
Number:3
Medical Hi
story Term
:Laparoscopic S
alpingectomy
Start Date: Dec/7/2018
Ongoing: NO
End Date:
Dec/7/2018
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838743
Page 98 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:16:38
(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-21-2020
13:16:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Laparoscopic Salpingecto
myInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-21-2020
13:16:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-21-2020
13:16:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/7/2018Initial Entry
1.d
Date Location User Value Reason
Sep-21-2020 13:17:27 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838744
Page 99 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) Line/MH Num
ber:4
Medical Histor
y Term:Cystoscop
y
Start Date: Dec/7/201
8
Ongoing: NO
End Date
:
Dec/7/2
018
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838745
Page 100 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:17:27
(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-21-2020
13:17:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CystoscopyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-21-2020
13:17:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-21-2020
13:17:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/7/2018Initial Entry
1.e
Date Location User Value Reason
Sep-21-2020 13:18:50 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838746
Page 101 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) Line/MH Nu
mber:5
Medical Hist
ory Term:Hypertension
(Chronic)
Start Date: Dec/11/2017
Ongoing: YES
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838747
Page 102 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:18:50
(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-21-2020
13:18:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Hypertension (Chronic)Initial Entry
1.e Start Date:
Date Location User Value Reason
Sep-21-2020
13:18:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/11/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-21-2020
13:18:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-21-2020 13:19:16
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 6Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838748
Page 103 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) er:
Medical History
Term:Obesity
Start Date: Dec/11/2
017
Ongoing: YES
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838749
Page 104 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:19:16
(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-21-2020
13:19:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-21-2020
13:19:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/11/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-21-2020
13:19:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-21-2020 13:19:50
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 7Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838750
Page 105 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) mber:
Medical Hist
ory Term:Iron Deficien
cy Anemia
Start Date: Apr/4/2018
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:19:50
(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-21-2020
13:19:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Iron Deficiency AnemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-21-2020
13:19:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/4/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-21-2020
13:19:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838751
Page 106 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h
Date Location User Value Reason
Sep-21-2020 13:20:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Low Back
Pain
Start Date: Apr/4/201
8
Ongoing: YESInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838752
Page 107 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:20:13
(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-21-2020
13:20:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low Back PainInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-21-2020
13:20:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/4/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-21-2020
13:20:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-21-2020 13:21:14
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH 9Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838753
Page 108 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) Number:
Medical H
istory Ter
m:Reactive Airwa
y Disease (Chr
onic)
Start Date
:Apr/7/2019
Ongoing: YES
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838754
Page 109 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.i Line/MH Number:
Date Location User Value Reason
Sep-21-2020 13:21:14
(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-21-2020
13:21:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Reactive Airway Disease (
Chronic)Initial Entry
1.i Start Date:
Date Location User Value Reason
Sep-21-2020
13:21:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/7/2019Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-21-2020
13:21:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838755
Page 110 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-21-2020
13:22:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838756
Page 111 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
122.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
170.7Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838757
Page 112 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-21-2020 13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
42.2Initial Entry
7.a
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identi
fier::1
Temperature: 98.8
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-21-2020
13:23:30ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838758
Page 113 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)
7.a Unit:
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-21-2020
13:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838759
Page 114 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-21-2020 13:24:05
(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-21-2020 13:24:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-21-2020
13:24:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-21-2020 13:24:05
(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-21-2020 13:24:05 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838760
Page 115 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) URINE
6.a
Date Location User Value Reason
Sep-21-2020 13:24:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-21-2020 13:24:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-21-2020
13:24:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_
PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-21-2020
13:24:05ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838761
Page 116 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838762
Page 117 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-21-2020
13:24:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-21-2020
13:24:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
94345Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838763
Page 118 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 13:24:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 13:24:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020
15:56:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-21-2020
13:24:43
(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-21-2020
13:24:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838764
Page 119 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep/21/2020
5.a
Date Location User Value Reason
Sep-21-2020
15:56:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP959XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020
15:56:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP959XInitial Entry
5.b
Date Location User Value Reason
Sep-21-2020
15:56:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP959YInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-21-2020
15:56:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP959YInitial Entry
5.c
Date Location User Value Reason
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838765
Page 120 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-21-2020
15:57:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP959ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-21-2020
15:57:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP959ZInitial Entry
5.d
Date Location User Value Reason
Oct-02-2020
12:53:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNMRSInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-02-2020
12:53:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNMRSInitial Entry
5.e
Date Location User Value Reason
Oct-02-2020
12:53:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNMRTInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (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-2021-5683-0838766
Page 121 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.e Sample ID
Date Location User Value Reason
Oct-02-2020
12:53:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNMRTInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0838767
Page 122 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 13:24:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 13:24:50
(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-21-2020
15:57:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-21-2020
13:24:50
(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-21-2020
13:24:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838768
Page 123 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep/21/2020
5.a
Date Location User Value Reason
Sep-21-2020
15:57:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP95B0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020
15:57:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP95B0Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838769
Page 124 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-21-2020
13:26:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 13:26:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 13:26:10
(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-21-2020
13:26:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020 11:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 13:26:10 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838770
Page 125 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) DELTOID MUSCLE
6. Body Side:
Date Location User Value Reason
Sep-21-2020
13:26:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020 13:26:10
(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-21-2020 13:26:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-21-2020
13:26:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838771
Page 126 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-21-2020
13:26:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLLE
CTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838772
Page 127 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-13-2020
10:58:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838773
Page 128 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-13-2020
10:59:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2.a
Date Location User Value Reason
Oct-13-2020
10:59:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identi
fier::1
Temperature: 99.0
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-13-2020
10:59:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-13-2020
10:59:44
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
99.0Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838774
Page 129 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
2.a Unit:
Date Location User Value Reason
Oct-13-2020
10:59:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-13-2020
10:59:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838775
Page 130 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Specimen Type:
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838776
Page 131 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined
Identifier:Not D
one
Test:: Not D
one
Result:: Not D
one
Not Done:: Not D
oneInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838777
Page 132 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
6.a Result:
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-13-2020
11:00:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838778
Page 133 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 11:02:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 11:02:32
(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-13-2020
17:14:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
11:02:32
(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-13-2020
11:02:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838779
Page 134 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct/13/2020
5.a
Date Location User Value Reason
Oct-13-2020
17:14:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY452Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020
17:14:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY452Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838780
Page 135 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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-13-2020
11:03:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-13-2020 11:03:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020 11:03:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-13-2020
11:03:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020 10:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020 11:03:09 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838781
Page 136 of 155
***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: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) DELTOID MUSCLE
6. Body Side:
Date Location User Value Reason
Oct-13-2020
11:03:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-13-2020 11:03:09
(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
Oct-13-2020 11:03:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Oct-13-2020
11:03:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838782
Page 137 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020
11:44:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/16/2020Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838783
Page 138 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
11:45:06 (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
11:45:06 (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
17:05:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-16-2020
11:45:06
(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
11:45:06ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838784
Page 139 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)Date of Collection:
Nov/16/2020
5.a
Date Location User Value Reason
Nov-16-2020
17:05:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9YXGInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-16-2020
17:05:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR9YXGInitial Entry
5.b
Date Location User Value Reason
Nov-18-2020
16:49:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS68H6Transcription
Error
Nov-18-2020
16:49:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS68HGInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838785
Page 140 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Sample ID
Date Location User Value Reason
Nov-18-2020
16:49:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS68H6Transcription
Error
Nov-18-2020
16:49:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS68HGInitial Entry
5.c
Date Location User Value Reason
Nov-18-2020
16:56:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS68H7Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-18-2020
16:56:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS68H7Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838786
Page 141 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-16-2020
11:51:16 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838787
Page 142 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020
11:51:16 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020
11:51:16 (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 ValueReason
Nov-17-2020
12:40:35
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Nov-17-2020
10:59:44
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged
Information
Nov-17-2020
10:59:44
(UTC-08:00)ACV0PFEINFP6000 Data
Entry
:Changed
Information
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838788
Page 143 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time
(US &
Canada)Sore a
nd sw
ollen
under
arm l
ymph
node (
both a
rms)
Nov-16-2020
17:54:59
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify BOTH
UNDERARM
LYMPH
NODE as
follows...Body
site only
reported.
Specify the
corresponding
symptom,
diagnosis or
procedure
being reported
and update the
verbatim term
accordingly.
Thank you.
Nov-16-2020
11:51:16
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Both
under
arm l
ymph
nodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838789
Page 144 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/15/2020 UNK:UN
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838790
Page 145 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020
11:51:16
(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
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020
11:51:16ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838791
Page 146 of 155
***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, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020
11:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838792
Page 147 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-16-2020
11:45:44 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838793
Page 148 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-16-2020
11:45:44 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-16-2020
11:45:44 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-16-2020
11:45:44 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Nov-16-2020
11:45:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Flulaval Quadrivalent Infl
uenza VaccinationInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838794
Page 149 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5. Date:
Date Location User Value Reason
Nov-16-2020
11:45:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/16/2020Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838795
Page 150 of 155
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 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
Nov-16-2020
11:45:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-16-2020
11:45:17 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-16-2020
11:45:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838796
Page 151 of 155
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 17:10:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838797
Page 152 of 155
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-28-2021
17:10:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021
17:10:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Jan-28-2021
17:10:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to ret
urn for Vaccination 3
Participant is:
eligible and NOT confi
rmed to have received
only placebo at Vaccin
ation 1/2Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838798
Page 153 of 155
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-28-2021 17:10:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-28-2021 17:10:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACCI
NATIONInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838799
Page 154 of 155
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-16-2020
11:45:17 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-21-2020 13:24:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Sep-21-2020 13:12:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-16-2020
11:45:17 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/16/2020Initial Entry
Sep-21-2020 13:24:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
Sep-21-2020 13:12:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838800
Page 155 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1265 Site Name: (1265) Kaiser Permanente
Subject No: 12651149 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020
08:35:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 William
TownerData Entry:
Click Here to EnableInitial Entry
090177e196ae3037\Final\Final On: 01-Apr-2021 04:04 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838801