125742 S1 M5 CRF c4591001 1130 11301031

Document text

Page 1 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933667
Page 2 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933668
Page 3 of 230
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11301031]
2.Birth Date: /1939
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933669
Page 4 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933670
Page 5 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933671
Page 6 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933672
Page 7 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Breast Cancer]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumpectomy Right breast]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Breast Cancer]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933673
Page 8 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumpectomy, Left breast]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ATHEROSCLEROSIS OF AORTA (Chronic)]
Start Date: Nov/9/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic RHINOSINUSITIS]
Start Date: Mar/2/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: Apr/26/2016
Ongoing: YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933674
Page 9 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROIDISM]
Start Date: Aug/14/2017
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral hands, PERIPHERAL NEUROPATHY]
Start Date: Dec/17/2009
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS bilateral hands]
Start Date: Feb/25/2000
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis of back]
Start Date: Apr/25/2007
Ongoing: YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933675
Page 10 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ROSACEA]
Start Date: Nov/17/2000
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SPINAL STENOSIS OF LUMBAR SPINE]
Start Date: Jul/30/2019
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SPONDYLOSIS CERVICAL JOINT Without MYELOPATHY]
Start Date: Nov/26/2003
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: Mar/24/1995
Ongoing: YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933676
Page 11 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BASAL CELL CARCINOMA, FACE LEFT FOREHEAD ABOVE
EYEBROW]
Start Date: Feb/5/2002
Ongoing: NO
End Date:
Feb/5/2002
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Mohs micrographic surgery to Left face basal cell carcinoma]
Start Date: Feb/5/2002
Ongoing: NO
End Date:
Feb/5/2002
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933677
Page 12 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [50.8]
3.Unit: kg
4.Height: [152.4]
5.Unit: cm
6.Body Mass Index: [21.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933678
Page 13 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/2/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933679
Page 14 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [250094]
3.Randomization Group: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933680
Page 15 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BP0X1D]
5.bSample ID [BP0X1F]
5.cSample ID [BP0X1G]
5.dSample ID [BPHTTW]
5.eSample ID [BPHTTV]
5.fSample ID [BPHTTT]
5.gSample ID [BPHTTS]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933681
Page 16 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BP0X1L]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933682
Page 17 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/2/2020 14:18
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
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933683
Page 18 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933684
Page 19 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933685
Page 20 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933686
Page 21 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
Not Done: NOT DONE
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933687
Page 22 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [BP0X7H]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933688
Page 23 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 10:24
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
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933689
Page 24 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933690
Page 25 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BR8MW5]
5.bSample ID [BR8MW6]
5.cSample ID [BS6ZSR]
5.dSample ID [BS6ZSS]
5.eSample ID [BS6ZST]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933691
Page 26 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933692
Page 27 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933693
Page 28 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933694
Page 29 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933695
Page 30 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933696
Page 31 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933697
Page 32 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933698
Page 33 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933699
Page 34 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933700
Page 35 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933701
Page 36 of 230
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933702
Page 37 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933703
Page 38 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933704
Page 39 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933705
Page 40 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Rash - injection site
 Feb/9/2021
19:00 NO
End Date Time:
Feb/19/2021 UNK:U
NK
 Repeating
Pages
 2.ADVERSE E
VENT 2  Rash- various place
s on body Feb/9/2021
19:00 NO
End Date Time:
Feb/19/2021 UNK:U
NK
 Repeating
Pages
 3.ADVERSE E
VENT 3  Transient Ischemic
Attack Mar/7/2021
08:00 NO
End Date Time:
Mar/7/2021 10:07
 Repeating
Pages
 4.ADVERSE E
VENT 4  Urinary Tract Infect
ion Mar/7/2021
09:48 YES  Repeating
Pages
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933706
Page 41 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[Rash - injection site]
4.Start Date Time: Feb/9/2021 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/19/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933707
Page 42 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933708
Page 43 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Rash- various places on body]
4.Start Date Time: Feb/9/2021 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/19/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).NO
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933709
Page 44 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933710
Page 45 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Transient Ischemic Attack]
4.Start Date Time: Mar/7/2021 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/7/2021 10:07
6.Toxicity Grade: 2
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933711
Page 46 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Related to hypercholesterolemia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933712
Page 47 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[2021264920]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933713
Page 48 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Urinary Tract Infection]
4.Start Date Time: Mar/7/2021 09:48
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933714
Page 49 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bacteria in the Urinary Tract]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933715
Page 50 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categ
oryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933716
Page 51 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933717
Page 52 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of MedicationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  INFs Pres Free High Dose
(FLUZONE) (influenza) Oct/15
/2020 Repeating
Pages
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933718
Page 53 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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).[INFs Pres Free High Dose (FLUZONE) (influenza)]
5.Date: Oct/15/2020
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933719
Page 54 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933720
Page 55 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933721
Page 56 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933722
Page 57 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933723
Page 58 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933724
Page 59 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933725
Page 60 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933726
Page 61 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933727
Page 62 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933728
Page 63 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933729
Page 64 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933730
Page 65 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933731
Page 66 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933732
Page 67 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933733
Page 68 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933734
Page 69 of 230
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933735
Page 70 of 230
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933736
Page 71 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933737
Page 72 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/20/2021
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933738
Page 73 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933739
Page 74 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933740
Page 75 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/20/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933741
Page 76 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0XDS]
5.bSample ID [BP0XF7]
5.cSample ID [BPHV4J]
5.dSample ID [BPHV4K]
5.eSample ID [BPHV4L]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933742
Page 77 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0XDZ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933743
Page 78 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/20/2021 10:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933744
Page 79 of 230
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933745
Page 80 of 230
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/9/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933746
Page 81 of 230
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0XJD]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933747
Page 82 of 230
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/9/2021 10:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933748
Page 83 of 230
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933749
Page 84 of 230
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/9/2021
3.Comments: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933750
Page 85 of 230
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933751
Page 86 of 230
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933752
Page 87 of 230
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933753
Page 88 of 230
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933754
Page 89 of 230
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933755
Page 90 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933756
Page 91 of 230
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933757
Page 92 of 230
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933758
Page 93 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormSep-02-2020 13:46:03 (UTC-08:00)
Pacific Time (US & Canada)Tara Beatty Not Applicable
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933759
Page 94 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormJan-20-2021 10:17:41 (UTC-08:00)
Pacific Time (US & Canada)Dorothy
KurdylaNot Applicable
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933760
Page 95 of 230
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Tara Beatty  N/A Mar-09-2021 11:27:13 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Feb-21-2021 16:40:14 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Dorothy
Kurdyla N/A Feb-17-2021 10:39:54 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Feb-16-2021 11:21:09 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933761
Page 96 of 230
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, StephenFortmann, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-16-2021 10:29:42 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Feb-10-2021 10:32:37 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Kristi Bays  N/A Feb-09-2021 10:28:25 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Jan-22-2021 22:11:57 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933762
Page 97 of 230
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Dorothy
Kurdyla N/A Jan-20-2021 10:17:20 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Jan-18-2021 22:18:27 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Sperry
Robinson N/A Jan-15-2021 09:24:29 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Nov-16-2020 09:46:31 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933763
Page 98 of 230
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Tara Beatty  N/A Nov-13-2020 17:11:31 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Oct-27-2020 10:04:38 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933764
Page 99 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020 13:45:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020 13:45:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933765
Page 100 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020 13:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
OBTAINED
Date Written Consent Obta
ined
Sep/2/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933766
Page 101 of 230
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020 13:45:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11301031Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020 13:45:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1939Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020 13:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020 13:45:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH O
RIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020 13:45:38
(UTC-08:00) PacificACV0PFEINFP6000  Tara Beatty Data Entry:
WHITEInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933767
Page 102 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933768
Page 103 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 13:45:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Sep/2/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933769
Page 104 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020 13:46:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020 13:46:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020 13:46:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
COMPLETEDInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933770
Page 105 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020 13:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Right Breast
Cancer
Start Date: UNK/UNK/2
000
Ongoing: NO
End Date:
UNK/UN
K/2000Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:55:18
(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-02-2020 13:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Right Breast CancerInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933771
Page 106 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-02-2020 13:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020 13:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.b
Date Location User Value Reason
Sep-02-2020 13:56:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Lumpectomy
Right breast
Start Date: UNK/UNK/20
00
Ongoing: NO
End Date:
UNK/UNK/
2000Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933772
Page 107 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:56:39
(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-02-2020 13:56:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Lumpectomy Right breastInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 13:56:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 13:56:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.c
Date Location User Value Reason
Sep-02-2020 13:57:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933773
Page 108 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Histo
ry Term:Left Breast C
ancer
Start Date: UNK/UNK/2
005
Ongoing: NO
End Date:
UNK/UN
K/2005
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933774
Page 109 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:57:09
(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-02-2020 13:57:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Left Breast CancerInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020 13:57:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020 13:57:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.d
Date Location User Value Reason
Sep-02-2020 13:57:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933775
Page 110 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical His
tory Term:Lumpectomy,
Left breast
Start Date: UNK/UNK/20
05
Ongoing: NO
End Date:
UNK/UNK
/2005
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933776
Page 111 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:57:46
(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-02-2020 13:57:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Lumpectomy, Left breastInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-02-2020 13:57:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-02-2020 13:57:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.e
Date Location User Value Reason
Sep-02-2020 13:58:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933777
Page 112 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical
History T
erm:ATHEROSCLER
OSIS OF AORT
A (Chronic)
Start Dat
e:Nov/9/2019
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:58:37
(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-02-2020 13:58:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
ATHEROSCLEROSIS OF
AORTA (Chronic)Initial Entry
1.e Start Date:
Date Location User Value Reason
Sep-02-2020 13:58:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Nov/9/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-02-2020 13:58:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933778
Page 113 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f
Date Location User Value Reason
Sep-02-2020 13:59:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Chronic RHIN
OSINUSITIS
Start Date: Mar/2/2000
Ongoing: YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933779
Page 114 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:59:12
(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-02-2020 13:59:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Chronic RHINOSINUSITISInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-02-2020 13:59:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Mar/2/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-02-2020 13:59:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-02-2020 13:59:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933780
Page 115 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Hi
story Term
:HYPERCHOL
ESTEROLEMI
A
Start Date: Apr/26/2016
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:59:36
(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-02-2020 13:59:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
HYPERCHOLESTEROLE
MIAInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-02-2020 13:59:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Apr/26/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-02-2020 13:59:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.h
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933781
Page 116 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Sep-02-2020 14:00:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:HYPOTHYR
OIDISM
Start Date: Aug/14/2017
Ongoing: YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933782
Page 117 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:00:01
(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-02-2020 14:00:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
HYPOTHYROIDISMInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-02-2020 14:00:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Aug/14/2017Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-02-2020 14:00:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-02-2020 14:00:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933783
Page 118 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical
History T
erm:Bilateral hands, P
ERIPHERAL NE
UROPATHY
Start Dat
e:Dec/17/2009
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:00:50
(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-02-2020 14:00:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Bilateral hands, PERIPHER
AL NEUROPATHYInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-02-2020 14:00:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Dec/17/2009Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-02-2020 14:00:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933784
Page 119 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.j
Date Location User Value Reason
Sep-02-2020 14:01:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical Hi
story Term
:OSTEOARTHR
ITIS bilateral ha
nds
Start Date: Feb/25/2000
Ongoing: YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933785
Page 120 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.j Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:01:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 14:01:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
OSTEOARTHRITIS bilater
al handsInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-02-2020 14:01:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Feb/25/2000Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-02-2020 14:01:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933786
Page 121 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.k
Date Location User Value Reason
Sep-02-2020 14:02:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Histo
ry Term:Osteoporosi
s of back
Start Date: Apr/25/2007
Ongoing: YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933787
Page 122 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.k Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:02:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 14:02:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Osteoporosis of backInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-02-2020 14:02:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Apr/25/2007Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-02-2020 14:02:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-02-2020 14:02:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933788
Page 123 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History
Term:ROSACE
A
Start Date: Nov/17/2
000
Ongoing: YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933789
Page 124 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:02:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:02:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
ROSACEAInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-02-2020
14:02:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Nov/17/2000Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-02-2020
14:02:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Sep-02-2020 14:03:18 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933790
Page 125 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) Line/MH
Number:13
Medical
History T
erm:SPINAL STENO
SIS OF LUMBA
R SPINE
Start Dat
e:Jul/30/2019
Ongoing: YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933791
Page 126 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:03:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:03:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
SPINAL STENOSIS OF L
UMBAR SPINEInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-02-2020
14:03:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Jul/30/2019Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-02-2020
14:03:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Sep-02-2020 14:04:07 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933792
Page 127 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) Line/M
H Num
ber:14
Medica
l Histor
y Term:SPONDYLOSIS C
ERVICAL JOINT
Without MYELOP
ATHY
Start D
ate:Nov/26/2003
Ongoin
g:YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933793
Page 128 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.n Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:04:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:04:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
SPONDYLOSIS CERVICA
L JOINT Without MYELO
PATHYInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-02-2020
14:04:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Nov/26/2003Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-02-2020
14:04:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Sep-02-2020 14:11:52 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933794
Page 129 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) Line/MH
Number:15
Medical
History
Term:GASTROESOPH
AGEAL REFLU
X DISEASE
Start Dat
e:Mar/24/1995
Ongoing: YES
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933795
Page 130 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:11:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 14:11:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
GASTROESOPHAGEAL
REFLUX DISEASEInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-02-2020 14:11:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Mar/24/1995Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-02-2020 14:11:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Sep-03-2020
10:28:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Line/
MH
Numb16Transcription
Error
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933796
Page 131 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
er:
Medic
al His
tory T
erm:BASAL CELL CA
RCINOMA, FACE
LEFT FOREHEA
D ABOVE EYEB
ROW
Start
Date:Feb/5/2002
Ongoi
ng:NO
End Date:
Feb/5/2002
Sep-02-2020
14:12:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umbe
r:16
Medic
al Hist
ory Te
rm:BASAL CELL C
ARCINOMA, FA
CE Left FOREHE
AD SUPRABRO
W
Start
Date:Feb/5/2002
Ongoi
ng:NO
End Date:
Feb/5/2002Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933797
Page 132 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.p Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:12:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-03-2020
19:57:49
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Sep-03-2020
10:28:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Sep-03-2020
10:28:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Tara Beatty Data
Entry
:
BAS
AL C
ELL
CAR
CINO
MA,
FACE
LEFT
FORE
HEA
D ABTranscription
Error
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933798
Page 133 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
OVE
EYE
BRO
W
Sep-03-2020
05:53:45
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedClarify BASAL
CELL
CARCINOMA,
FACE LEFT
FOREHEAD
SUPRABROW
as
follows...Please
clarify
SUPRABROW
and edit the
term. If
reporting
BASAL CELL
CARCINOMA,
FACE LEFT
FOREHEAD
ABOVE
EYEBROW,
edit as such.
Otherwise
clarify and edit
the term as
appropriate.
Thank you.
Sep-02-2020
14:12:58
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Tara Beatty Data
Entry
:
BAS
AL C
ELL
CAR
CINOInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933799
Page 134 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
MA,
FACE
Left F
ORE
HEA
D SU
PRA
BRO
W
1.p Start Date:
Date Location User Value Reason
Sep-02-2020
14:12:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Feb/5/2002Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-02-2020
14:12:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date:
Feb/5/2002Initial Entry
1.q
Date Location User Value Reason
Sep-02-2020 14:14:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:17Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933800
Page 135 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medica
l Histor
y Term
:Mohs micrographic
surgery to Left face
basal cell carcinom
a
Start D
ate:Feb/5/2002
Ongoin
g:NO
End Date:
Feb/5/2002
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933801
Page 136 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.q Line/MH Number:
Date Location User Value Reason
Sep-02-2020 14:14:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:14:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Mohs micrographic surgery
to Left face basal cell carcin
omaInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-02-2020
14:14:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Feb/5/2002Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-02-2020
14:14:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date:
Feb/5/2002Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933802
Page 137 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
50.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
152.4Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
cmInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933803
Page 138 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.9Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Record Identifi
er::1
Temperature: 98.3
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933804
Page 139 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 14:04:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933805
Page 140 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020 15:25:31
(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-02-2020 15:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020
15:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020 15:25:31
(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-02-2020 15:25:31 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933806
Page 141 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) URINE
6.a
Date Location User Value Reason
Sep-02-2020 15:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020 15:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020
15:25:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Choriogonadotropin Beta_
PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020 ACV0PFEINFP6000  Sperry Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933807
Page 142 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
15:25:31
(UTC-08:00) Pacific
Time (US & Canada)Robinson NOT DONE
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933808
Page 143 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
15:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
15:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
250094Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933809
Page 144 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 15:18:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 15:18:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 15:18:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-02-2020 15:18:40
(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-02-2020 15:18:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi Bays Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933810
Page 145 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Sep-02-2020 15:18:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BP0X1DInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 15:18:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BP0X1DInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 15:19:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BP0X1FInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 15:19:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BP0X1FInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BP0X1GInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933811
Page 146 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 15:19:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BP0X1GInitial Entry
5.d
Date Location User Value Reason
Sep-02-2020 15:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BPHTTWInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-02-2020 15:20:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BPHTTWInitial Entry
5.e
Date Location User Value Reason
Sep-02-2020 15:20:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BPHTTVInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020 15:20:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BPHTTVInitial Entry
5.f
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933812
Page 147 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Sep-02-2020 15:20:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BPHTTTInitial Entry
5.f Sample ID
Date Location User Value Reason
Sep-02-2020 15:20:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BPHTTTInitial Entry
5.g
Date Location User Value Reason
Sep-02-2020 15:21:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BPHTTSInitial Entry
5.g Sample ID
Date Location User Value Reason
Sep-02-2020 15:21:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BPHTTSInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933813
Page 148 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 13:59:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 13:59:16
(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-02-2020 13:59:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-02-2020 13:59:16
(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-02-2020 13:59:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi Bays Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933814
Page 149 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Sep-02-2020 13:59:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BP0X1LInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 13:59:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BP0X1LInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933815
Page 150 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020
15:27:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 15:27:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 15:27:05
(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-02-2020
15:27:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Sep/2/2020 14:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 15:27:05 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933816
Page 151 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) DELTOID MUSCLE
6. Body Side:
Date Location User Value Reason
Sep-02-2020
15:27:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020 15:27:05
(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-02-2020 15:27:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-02-2020
15:27:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933817
Page 152 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020
15:26:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLLE
CTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933818
Page 153 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
04:18:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site
confirmation
Sep-29-2020
09:55:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Query 1: Answered Symptoms not
deemed Covid-19
symptoms during
conversation with
patient. Related
to dramatically
reduced air
quality d/t
extensive fires.
Note uploaded to
Florence.
Sep-29-2020
08:46:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
18SEP2020. But
there is no
COVID Illness
visit reported in
the database.
Please clarify.
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933819
Page 154 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-21-2020
14:36:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Sep/21/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933820
Page 155 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 14:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 14:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Record Identifi
er::1
Temperature: 97.8
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 14:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-21-2020 14:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
97.8Initial Entry
2.a Unit:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933821
Page 156 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Sep-21-2020 14:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 14:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933822
Page 157 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020 10:50:49
(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-22-2020 10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-22-2020
10:51:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-22-2020
10:51:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Sep/21/2020Transcription
Error
Sep-22-2020
10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Collection Date
22/Sep/2020 is
not the same as
the Date of Visit
21/Sep/2020.
Please correct or
confirm.
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933823
Page 158 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-22-2020
10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Sep/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020 10:50:49
(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-22-2020 10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-22-2020 10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933824
Page 159 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-22-2020 10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-22-2020
10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Choriogonadotropin Beta_
PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-22-2020
10:50:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
NOT DONEInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933825
Page 160 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 09:47:34
(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 09:47:34
(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 09:47:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-21-2020 09:47:34
(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 09:47:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi Bays Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933826
Page 161 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Sep-21-2020 09:47:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BP0X7HInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020 09:47:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BP0X7HInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933827
Page 162 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-21-2020
10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 10:45:06
(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 10:45:06
(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
10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020 10:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 10:45:06 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933828
Page 163 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) DELTOID MUSCLE
6. Body Side:
Date Location User Value Reason
Sep-21-2020
10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020 10:45:06
(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 10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-21-2020
10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933829
Page 164 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
09:30:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
Oct/19/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933830
Page 165 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 10:27:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 10:27:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 10:28:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020 10:27:56
(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-19-2020 10:27:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi Bays Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933831
Page 166 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Oct-19-2020 10:28:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BR8MW5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 10:28:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BR8MW5Initial Entry
5.b
Date Location User Value Reason
Oct-19-2020 10:28:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BR8MW6Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 10:28:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BR8MW6Initial Entry
5.c
Date Location User Value Reason
Oct-19-2020 10:28:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BS6ZSRInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933832
Page 167 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 10:28:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BS6ZSRInitial Entry
5.d
Date Location User Value Reason
Oct-19-2020 10:28:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BS6ZSSInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-19-2020 10:28:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BS6ZSSInitial Entry
5.e
Date Location User Value Reason
Oct-19-2020 10:29:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
Sample ID: BS6ZSTInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-19-2020 10:29:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Kristi
BaysData Entry:
BS6ZSTInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933833
Page 168 of 230
***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, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020
09:30:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 09:30:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
09:30:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
COMPLETEDInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933834
Page 169 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Feb-16-2021 10:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0933835
Page 170 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Feb-17-2021 10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaForm Created
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933836
Page 171 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Mar-09-2021 11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Form Created
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933837
Page 172 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Mar-09-2021 11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Form Created
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933838
Page 173 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 10:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 10:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-17-2021
12:46:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clos
edDiscrepancy
has been
closed.
Feb-17-2021
10:42:17
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredChanged
Information
Feb-17-2021
10:42:17
(UTC-08:00)
Pacific Time
(US &ACV0PFEINFP6000  Dorothy
KurdylaData E
ntry:
Rash - i
njectio
n siteChanged
Information
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933839
Page 174 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Canada)
Feb-16-2021
14:38:20
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Open
edMultiple
concepts in
the term
RASH -
INJECTION
SITE AND
VARIOUS
PLACES
ON BODY.
Split the
term into
RASH -
INJECTION
SITE and
RASH
VARIOUS
PLACES
ON BODY
and report as
separate
entries.
Thank you.
Feb-16-2021
10:29:42
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Rash - i
njectio
n site a
nd vari
ous pla
ces on
bodyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021
10:29:42ACV0PFEINFP6000  Data Entry:
Feb/9/2021 19:00Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0933840
Page 175 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021
11:24:06
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Mar-11-2021
11:24:06
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date Time:
Feb/19/2021 UNK:U
NKNew Information
Mar-10-2021
06:08:22
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
Rash inj site (09
Feb 21) related to
Vax 4, is still
indicated as
ONGOING.
Please review and
confirm
ONGOING, or
enter END date if
known.
Feb-16-2021
10:29:42
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0933841
Page 176 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-17-2021
22:10:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-17-2021
10:39:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-17-2021
10:39:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
1Initial Entry
Feb-16-2021
21:40:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Toxicity
Grade" is
missing. Kindly
review and
update.
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
Feb-16-2021
10:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0933842
Page 177 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Feb-16-2021
10:29:42
(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
Feb-17-2021
22:10:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-17-2021
10:40:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-17-2021
10:40:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
RELATEDInitial Entry
Feb-16-2021
21:40:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for "Is
this event related
to study
treatment" is
missing. Kindly
review and
update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021
10:29:42
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0933843
Page 178 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021
10:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021
10:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021
11:24:40
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-11-2021
11:24:40
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
RECOVERED/RESOL
VEDNew Information
Mar-11-2021
11:24:06
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Rash -
injection site:
Response to
"What was the
outcome of this
adverse event?" is
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0933844
Page 179 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Feb-16-2021
10:29:42
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-16-2021
10:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0933845
Page 180 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Feb-17-2021 10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-17-2021 10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
Rash- various places on bo
dyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
Feb/9/2021 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933846
Page 181 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-11-2021
11:25:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Mar-11-2021
11:25:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date Time:
Feb/19/2021 UNK:UN
KNew Information
Mar-10-2021
06:08:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
Rash BODY (09
Feb 21) related to
Vax 4, is still
indicated as
ONGOING.
Please review and
confirm
ONGOING, or
enter END date if
known.
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0933847
Page 182 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933848
Page 183 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021
11:25:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-11-2021
11:25:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
RECOVERED/RESOLV
EDNew Information
Mar-11-2021
11:25:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Rash-
various places on
body: Response to
"What was the
outcome of this
adverse event?" is
'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933849
Page 184 of 230
***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, Answered Queries
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
NOT RECOVERED/NO
T RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-17-2021
10:43:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
NOInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933850
Page 185 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Transient Ischemic AttackInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Mar/7/2021 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933851
Page 186 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NO
End Date Time:
Mar/7/2021 10:07Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021
10:21:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed data updated
Mar-11-2021
07:04:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-11-2021
07:04:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
2Initial Entry
Mar-09-2021
22:12:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Toxicity
Grade" is
missing. Kindly
review and
update.
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).
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933852
Page 187 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Mar-12-2021
06:39:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-09-2021
17:56:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Transient
Ischemic Attack:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Mar-09-2021
17:56:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
YES
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NOInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933853
Page 188 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Is this serious event life th
reatening?
NO
Other medically important
serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021
10:21:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed data updated
Mar-11-2021
07:04:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is
due to:
OTHER
If Other, specify:
Related to hyperchoTranscription
Error
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933854
Page 189 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
lesterolemia
Mar-11-2021
07:04:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-11-2021
07:04:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is
due to:
OTHERInitial Entry
Mar-09-2021
22:12:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for "Is
this event related
to study
treatment" is
missing. Kindly
review and
update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933855
Page 190 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-09-2021
11:29:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-12-2021
06:39:10 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
2021264920Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933856
Page 191 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Urinary Tract InfectionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Mar/7/2021 09:48Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933857
Page 192 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021
10:22:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed data updated
Mar-11-2021
07:05:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-11-2021
07:05:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
1Initial Entry
Mar-09-2021
22:13:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Toxicity
Grade" is
missing. Kindly
review and
update.
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
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933858
Page 193 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021
12:49:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Mar-12-2021
08:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Mar-12-2021
08:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is
due to:
OTHER
If Other, specify:
Bacteria in the Urin
ary TractTranscription
Error
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933859
Page 194 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-11-2021
20:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opene
dDM: Please
clarify other,
unknown is not
valid response.
Thank you.
Mar-11-2021
11:16:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Mar-11-2021
11:16:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is
due to:
OTHER
If Other, specify:
UnknownTranscription
Error
Mar-11-2021
10:23:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opene
dResponse to 'If
other, specify' is
NOT RELATED,
please consider
updating this
field to what is
causing this AE.
Mar-11-2021
07:06:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is
due to:
OTHER
If Other, specify:Transcription
Error
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933860
Page 195 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Not related
Mar-11-2021
07:05:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-11-2021
07:05:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT RELATEDInitial Entry
Mar-09-2021
22:13:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for "Is
this event related
to study
treatment" is
missing. Kindly
review and
update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933861
Page 196 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
RECOVERING/RESOLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-09-2021
11:42:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
NOInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933862
Page 197 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Nov-13-2020 17:11:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Form Created
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933863
Page 198 of 230
***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, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-13-2020 17:11:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-13-2020 17:11:31
(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-13-2020 17:11:31
(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-13-2020
17:11:31 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
INFs Pres Free High Dose (
FLUZONE) (influenza)Initial Entry
5. Date:
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933864
Page 199 of 230
***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, Locked, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Nov-13-2020
17:11:31 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Tara Beatty Data Entry:
Oct/15/2020Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933865
Page 200 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-15-2021
09:24:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Jan/15/2021Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933866
Page 201 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-15-2021
09:24:52
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021
09:24:41
(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-15-2021
09:24:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Participant is willing to r
eturn for Vaccination 3
Participant is:
eligible per other prot
ocol allowance(s) and
confirmed to have rec
eived only placebo at
Vaccination 1/2Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933867
Page 202 of 230
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-15-2021
09:24:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
Jan/15/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-15-2021
09:24:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Sperry
RobinsonData Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACC
INATIONInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933868
Page 203 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-20-2021 10:17:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
Jan/20/2021Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933869
Page 204 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-20-2021 10:17:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
OBTAINED
Date Written Consent Obt
ained
Jan/20/2021Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933870
Page 205 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-20-2021 10:17:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
Jan/20/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-20-2021 10:17:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-20-2021 10:17:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Dorothy
KurdylaData Entry:
COMPLETEDInitial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933871
Page 206 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-20-2021 11:23:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-20-2021 11:23:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-20-2021
11:23:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-20-2021 11:23:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-20-2021 11:23:58 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933872
Page 207 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-08:00) Pacific
Time (US & Canada)(autocalc) URINE
6.a
Date Location User Value Reason
Jan-20-2021 11:23:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-20-2021 11:23:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-20-2021
11:23:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_
PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-20-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933873
Page 208 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
11:23:45
(UTC-08:00) Pacific
Time (US & Canada)NOT DONE
090177e196ae3d44\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933874
Page 209 of 230
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health
Research
Subject No: 11301031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021 11:18:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021 11:18:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021 11:18:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-20-2021 11:18:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate '
…[truncated]