125742 S1 M5 CRF c4591001 1068 10681091

Document text

Page 1 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918701
Page 2 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918702
Page 3 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10681091]
2.Birth Date: 1951
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:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918703
Page 4 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918704
Page 5 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918705
Page 6 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918706
Page 7 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteopenia]
Start Date: Aug/1/2018
Ongoing: YES
1.bLine/MH Number: [2] Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[recurrent cold sores] Comments
Start Date: UNK/UNK/1960 Comments
Ongoing: YES Comments
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[menopause syndrome]
Start Date: Jan/28/2018
Ongoing: NO
End Date:
Jun/22/2018
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918707
Page 8 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [57.47]
3.Unit: kg
4.Height: [164.5]
5.Unit: cm
6.Body Mass Index: [21.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918708
Page 9 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918709
Page 10 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [249490]
3.Randomization Group: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918710
Page 11 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [BNZPJR]
5.bSample ID [BNZPJP]
5.cSample ID [BNZPJN]
5.dSample ID [BPHSFC]
5.eSample ID [BPHSFD]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918711
Page 12 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [BNZPJL]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918712
Page 13 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 12:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918713
Page 14 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918714
Page 15 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918715
Page 16 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918716
Page 17 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918717
Page 18 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BNZPSN]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918718
Page 19 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/23/2020 17:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918719
Page 20 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918720
Page 21 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZP7H]
5.bSample ID [BNVXHM]
5.cSample ID [BNVXGY]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918721
Page 22 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918722
Page 23 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918723
Page 24 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918724
Page 25 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918725
Page 26 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918726
Page 27 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918727
Page 28 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918728
Page 29 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918729
Page 30 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918730
Page 31 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918731
Page 32 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918732
Page 33 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918733
Page 34 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918734
Page 35 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918735
Page 36 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Left Hip Fracture
 Jan/20/2021 12:22
 YES  Repeating
Pages
 2.ADVERSE EV
ENT 2  Fall  Jan/20/2021 12:22
 NO
End Date Time:
Jan/20/2021 UNK:UNK
 Repeating
Pages
 3.ADVERSE EV
ENT 3  Syncopal Episode
 Jan/22/2021 UNK
:UNK NO
End Date Time:
Jan/22/2021 UNK:UNK
 Repeating
Pages
 4.ADVERSE EV
ENT 4  orthostatic hypote
nsion Jan/22/2021 10:00
 NO
End Date Time:
Jan/22/2021 10:00
 Repeating
Pages
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918736
Page 37 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[Left Hip Fracture]
4.Start Date Time: Jan/20/2021 12:22
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918737
Page 38 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
[incidental, caused by fall on ice]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
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[2021051305]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918738
Page 39 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[Fall]
4.Start Date Time: Jan/20/2021 12:22
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[icy conditions caused fall]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918739
Page 40 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918740
Page 41 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[Syncopal Episode]
4.Start Date Time: Jan/22/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[cause unknown]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918741
Page 42 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918742
Page 43 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[orthostatic hypotension]
4.Start Date Time: Jan/22/2021 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 10:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[cause unknown]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918743
Page 44 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918744
Page 45 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918745
Page 46 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918746
Page 47 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918747
Page 48 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918748
Page 49 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918749
Page 50 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918750
Page 51 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918751
Page 52 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918752
Page 53 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918753
Page 54 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918754
Page 55 of 217
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918755
Page 56 of 217
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918756
Page 57 of 217
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918757
Page 58 of 217
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918758
Page 59 of 217
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918759
Page 60 of 217
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918760
Page 61 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918761
Page 62 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918762
Page 63 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918763
Page 64 of 217
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918764
Page 65 of 217
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918765
Page 66 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918766
Page 67 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/29/2021
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918767
Page 68 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918768
Page 69 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/29/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918769
Page 70 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/29/2021
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
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918770
Page 71 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BNZPCY]
5.bSample ID [BNVX4J]
5.cSample ID [BNVX4K]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918771
Page 72 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BNZPCW]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918772
Page 73 of 217
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/29/2021 15:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918773
Page 74 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918774
Page 75 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918775
Page 76 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
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 [BP1CD4]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918776
Page 77 of 217
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/19/2021 15:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918777
Page 78 of 217
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918778
Page 79 of 217
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918779
Page 80 of 217
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918780
Page 81 of 217
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918781
Page 82 of 217
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918782
Page 83 of 217
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918783
Page 84 of 217
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918784
Page 85 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918785
Page 86 of 217
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918786
Page 87 of 217
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andrew
Gentry Approved Mar-10-2021 07:38:47 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918787
Page 88 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-03-2020 08:51:59 (UTC-07:00)
Mountain Time (US & Canada)Emily
AnglemyerNot Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918788
Page 89 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.bSep-03-2020 08:54:25 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerepisodic outbreaks. typically <2 outbreaks /
year.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918789
Page 90 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.bSep-03-2020 08:54:25 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerepisodic outbreaks. typically <2 outbreaks /
year.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918790
Page 91 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.bSep-03-2020 08:54:25 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerepisodic outbreaks. typically <2 outbreaks /
year.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918791
Page 92 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.bSep-03-2020 08:54:25 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyerepisodic outbreaks. typically <2 outbreaks /
year.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918792
Page 93 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-03-2020 09:23:40 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918793
Page 94 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918794
Page 95 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918795
Page 96 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918796
Page 97 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918797
Page 98 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918798
Page 99 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918799
Page 100 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918800
Page 101 of 217
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-03-2020 09:23:40 (UTC-07:00) Mountain
Time (US & Canada)Emily
Anglemyermenopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918801
Page 102 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918802
Page 103 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918803
Page 104 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918804
Page 105 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918805
Page 106 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918806
Page 107 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918807
Page 108 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918808
Page 109 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918809
Page 110 of 217
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-24-2020 13:31:10 (UTC-07:00) Mountain
Time (US & Canada)Post menopause
Not Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0918810
Page 111 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-29-2021 15:35:42 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Applicable
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918811
Page 112 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-19-2021 16:07:05 (UTC-07:00)
Mountain Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918812
Page 113 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Feb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918813
Page 114 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Feb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918814
Page 115 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Feb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918815
Page 116 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Feb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918816
Page 117 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Feb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918817
Page 118 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918818
Page 119 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918819
Page 120 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-19-2021 16:07:05 (UTC-07:00) Mountain
Time (US & Canada)Emily
AnglemyerNot Done
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918820
Page 121 of 217
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andrew
Gentry Approved Mar-10-2021 07:38:47 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
Michaela
ODonoghue N/A Jan-27-2021 10:04:01 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Jan-26-2021 17:25:18 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
Michaela
ODonoghue N/A Jan-22-2021 14:50:42 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918821
Page 122 of 217
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Andrew
Gentry Approved Jan-22-2021 11:52:22 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
Michaela
ODonoghue N/A Jan-20-2021 17:10:12 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Oct-26-2020 15:50:37 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, 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.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918822
Page 123 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020 08:50:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020 08:50:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918823
Page 124 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 08:51:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
OBTAINED
Date Written Consent Obtai
ned
Sep/2/2020Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918824
Page 125 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 08:50:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10681091Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 08:50:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 08:51:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 08:51:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020 08:51:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
WHITEInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918825
Page 126 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 08:51:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sep/2/2020Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918826
Page 127 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020 08:52:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 08:52:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 08:52:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918827
Page 128 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 08:53:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:osteopenia
Start Date: Aug/1/201
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:53:42
(UTC-07:00) Mountain
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-03-2020 08:53:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
osteopeniaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 08:53:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Aug/1/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 08:53:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YESInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918828
Page 129 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b
Date Location User Value Reason
Sep-03-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:recurrent cold
sores
Start Date: UNK/UNK/1
960
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:54:02
(UTC-07:00) Mountain
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-03-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
recurrent cold soresInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
UNK/UNK/1960Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YESInitial Entry
1.c
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918829
Page 130 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-03-2020 08:56:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:menopause syn
drome
Start Date: Jan/28/2018
Ongoing: NO
End Date:
Jun/22/2018Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918830
Page 131 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:56:12
(UTC-07:00) Mountain
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-03-2020 08:56:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
menopause syndromeInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 08:56:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Jan/28/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-09-2020 08:44:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-09-2020 07:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-09-2020 07:47:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened confirm if
menopause is
considered
ongoing
Sep-03-2020 08:56:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
NO
End Date:
Jun/22/2018Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918831
Page 132 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
57.47Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
164.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918832
Page 133 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.2Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Record Identifier
::1
Temperature: 98.6
Temperature Uni
t:F
Temperature Loc
ation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918833
Page 134 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-03-2020 08:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
FOREHEADInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918834
Page 135 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918835
Page 136 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sponsor-Defined
Identifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-03-2020 09:23:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918836
Page 137 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 09:24:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 09:24:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
249490Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918837
Page 138 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 14:09:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 09:24:46
(UTC-07:00) Mountain
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-03-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 14:09:50 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0918838
Page 139 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00) Mountain
Time (US & Canada)Sample ID: BNZPJR
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 14:09:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNZPJRInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 14:10:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNZPJPInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 14:10:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNZPJPInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 14:10:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNZPJNInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 14:10:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNZPJNInitial Entry
5.d
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0918839
Page 140 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-21-2020 14:51:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sample ID: BPHSFCInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-21-2020 14:51:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BPHSFCInitial Entry
5.e
Date Location User Value Reason
Oct-21-2020 14:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sample ID: BPHSFDInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-21-2020 14:51:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BPHSFDInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918840
Page 141 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 09:27:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 09:27:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 14:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 09:27:31
(UTC-07:00) Mountain
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-03-2020 09:27:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 14:11:22 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0918841
Page 142 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00) Mountain
Time (US & Canada)Sample ID: BNZPJL
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 14:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNZPJLInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0918842
Page 143 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sep/2/2020 12:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918843
Page 144 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-03-2020 09:28:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YESInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918844
Page 145 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020 09:28:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918845
Page 146 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 13:30:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918846
Page 147 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 13:30:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 13:30:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.0
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 13:30:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 13:30:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 13:30:47
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0918847
Page 148 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020 13:30:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0918848
Page 149 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918849
Page 150 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-24-2020 13:31:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918850
Page 151 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 13:31:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 13:31:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 10:45:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-25-2020 01:46:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 13:31:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 13:31:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918851
Page 152 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a
Date Location User Value Reason
Sep-25-2020 10:45:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNZPSNInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 10:45:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNZPSNInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918852
Page 153 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 17:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918853
Page 154 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-24-2020 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918854
Page 155 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 16:53:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Oct/22/2020Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918855
Page 156 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 16:54:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 16:54:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 09:53:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-24-2020 02:40:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 16:54:00
(UTC-07:00) Mountain
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-22-2020 16:54:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YES
Date of Collection:Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918856
Page 157 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct/22/2020
5.a
Date Location User Value Reason
Oct-26-2020 09:53:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sample ID: BNZP7HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020 09:53:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BNZP7HInitial Entry
5.b
Date Location User Value Reason
Oct-26-2020 10:00:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sample ID: BNVXHMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 10:00:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BNVXHMInitial Entry
5.c
Date Location User Value Reason
Oct-26-2020 10:00:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sample ID: BNVXGYInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918857
Page 158 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 10:00:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BNVXGYInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918858
Page 159 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-23-2020 13:20:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-23-2020 13:20:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-23-2020 13:20:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918859
Page 160 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Jan-20-2021 17:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueForm Created
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918860
Page 161 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueForm Created
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918861
Page 162 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueForm Created
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918862
Page 163 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueForm Created
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918863
Page 164 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Jan-20-2021 17:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-08-2021 20:33:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-08-2021 16:43:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 1: Answered Changed data per
query
Feb-07-2021 12:04:10
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened per discharge
summary subject
had a syncopal
event on 1/22/21
during the
hospital stay,
please revisit and
update.
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain 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-28-2021 18:49:54
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918864
Page 165 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-25-2021 08:23:10
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 2: Answered added in updated
report as sent
Feb-23-2021 12:40:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical Please
add FALL
information in the
SAE Narrative, as
causing the SAE
(not in the SAE
Event term
section), as a SAE
safety update
Feb-08-2021 15:25:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 2: Answered Changed data per
query
Feb-04-2021 09:50:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 2: Opened Clinical - please
add fall
information to
SAE narrative, as
causative for the
Hip Fx SAE, in a
SAE safety update
Feb-04-2021 09:49:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-29-2021 09:53:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 1: Answered Changed data per
query
Jan-25-2021 09:34:55
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Please
submit SAE safety
update to report
clinical course
including any
surgery (include
date) performed;
any prior
medications; any
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918865
Page 166 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
in-hospital
medications
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
Left Hip FractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-20-2021 17:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
Jan/20/2021 12:22Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 18:55:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Mar-05-2021 12:34:25
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 4: Answered hip fracture not
resolved yet. will
continue to follow
and update end
date at time of
resolution based on
PI designation.
Mar-04-2021 18:14:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 4: Opened Clinical Please
review for End
date on this event,
which continues at
grade 4 severity
Feb-25-2021 08:26:34
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
YESChanged
Information
Feb-08-2021 20:34:44
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918866
Page 167 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada)
Feb-08-2021 16:43:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered New Information
Feb-08-2021 16:43:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NO
End Date Time:
Jan/23/2021 10:17New Information
Feb-07-2021 11:59:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 3: Opened Discharge
summary indicate
subject was
discharged from
hospital on 1/23/21
at 1:17 am, please
revisit and update
as needed
Feb-07-2021 11:50:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-01-2021 09:14:06
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 2: Answered will upload
Jan-29-2021 17:00:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 2: Opened Source unable in
e-Chart for
verification, please
revisit and upload
the hospital
discharge
summary, AE
worksheet with PI
determination ans a
copy of the SAE
submission to
safety in the
eSouce as needed.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918867
Page 168 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-27-2021 13:28:44
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Jan-27-2021 10:04:59
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 1: Answered Changed data per
query
Jan-22-2021 16:39:18
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Fall
is a one-day event,
please review if an
end date can be
applied to this
entry
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-02-2021 10:26:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-01-2021 14:37:04
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-01-2021 14:37:04
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
4Transcription Error
Feb-26-2021 10:35:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened GPD
CLINQUERY:
Please confirm that
the AE has a
toxicity grade of 2,
given that it is
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918868
Page 169 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
recorded as
serious, or update
accordingly.
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-04-2021
18:05:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-04-2021
15:45:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 2: Answered pyelonephritis
unrelated to this
participants SAE, not
in participant's
medical history.
Please clarify.
Thanks!
Mar-04-2021
10:30:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Query 2: Reissued:Opene
dCLINICAL - Thank
you. Indication for
ceftriaxone and
cefuroxime in SAE
con meds section is
'INFECTION'; as this
infection was
pyelonephritis that
was ongoing prior to
HOSP, please update
the indication for
both to
'PYELONEPHRITIS'
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918869
Page 170 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-29-2021 09:53:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 2: Answered Changed data per
query
Jan-25-2021 09:33:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID test
status (yes/no) during
Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2021051305] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
Jan-25-2021 09:33:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Query 2: Candidate Clinical COVID test
status (yes/no) during
Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2021051305] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
Jan-21-2021 03:44:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Left Hip
Fracture: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918870
Page 171 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event re
sult in death?
NO
Did this serious event re
quire or prolong hospital
ization?
YES
Did this serious event re
sult in persistent or signi
ficant disability/incapaci
ty?
NO
Is this serious event life t
hreatening?
NO
Other medically importa
nt serious event
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
Jan-20-2021 17:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918871
Page 172 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-22-2021 16:38:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Jan-22-2021 14:52:10
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 1: Answered Changed data per
query
Jan-22-2021 10:04:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Per
CRF completion
guidelines, 'Fall'
should be added as
a separate line
entry
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
incidental, caused by
fall on iceInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-20-2021 17:10:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT APPLICABLEInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918872
Page 173 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 15:47:54
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
YESTranscription
Error
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-25-2021
08:26:34
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Close
dClose Auto Query
Feb-25-2021
08:26:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Open
edFor AE Left Hip Fracture: Response
to "What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Feb-25-2021
08:26:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
RECOVERIN
G/RESOLVIN
GChanged Information
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918873
Page 174 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-16-2021
23:01:22
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Close
dSDB UPDATED. ISSUE
RESOLVED
Feb-12-2021
08:51:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reiss
ued:Candidatepending SDB update
Feb-11-2021
14:13:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 1: Answ
eredconfirm updated SAE form
submitted
Feb-11-2021
11:33:58
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reiss
ued:OpenedSAE RECON 1: Thanks for the
response. Outcome on CRF has not
been updated. If SAE follow up
form has been submitted, please
confirm.
Feb-10-2021
17:11:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueQuery 1: Answ
eredChanged data per query
Feb-10-2021
02:40:08
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Open
edSAE
RECON:AER#2021051305,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as
RECOVERED/RESOLVED WITH
SEQUELAE on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Feb-08-2021
16:38:55
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
RECOVERED
/RESOLVED
WITH SEQUE
LAENew Information
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918874
Page 175 of 217
***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, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-20-2021
17:10:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT RECOV
ERED/NOT R
ESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-20-2021 17:10:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-21-2021 03:44:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021051305Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918875
Page 176 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
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
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
FallInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
Jan/20/2021 12:22Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-27-2021 13:28:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Jan-27-2021 10:04:01
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918876
Page 177 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada)
Jan-27-2021 10:04:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NO
End Date Time:
Jan/20/2021 UNK:UNKTranscription Error
Jan-25-2021 07:58:52
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY:
Falls are one day
events - please
review for end date
Jan-22-2021 14:51:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
YESTranscription Error
Jan-22-2021 14:50:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NO
End Date Time:
Jan/20/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-04-2021 09:45:07
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 4: Closed hip fx SAE caused
hospitalization
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918877
Page 178 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-28-2021 08:15:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Jan-27-2021 10:04:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Changed
Information
Jan-27-2021 10:04:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed
Information
Jan-27-2021 10:04:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOChanged
Information
Jan-25-2021 09:32:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 4: Opened Clinical Please
clarify if event of
'fall' caused
Hospitalization or
if event of 'Lt hip
fracture' caused
Hospitalization.
Only one
responsible event is
required.
Jan-25-2021 06:19:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 3: Opened SAE RECON: Fall
is not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Jan-25-2021 06:19:21
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 2: Deleted Query can be
addressed
internally
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918878
Page 179 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-22-2021 14:51:14
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-22-2021 14:51:14
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData 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 req
uire or prolong hospitaliza
tion?
YES
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically important
serious event
NOTranscription Error
Jan-22-2021 14:50:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE Fall:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918879
Page 180 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Adverse Event
Number" is blank.
Jan-22-2021 14:50:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Is the adverse
event serious?' is
marked as YES, but
responses to all of
the seriousness
criteria are NO. At
least one
seriousness
criterion is
expected to be YES
for serious events.
Please review and
update as
appropriate.
Jan-22-2021 14:50:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData 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 req
uire or prolong hospitaliza
tion?
NO
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918880
Page 181 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
NO
Other medically important
serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
icy conditions caused f
allInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-22-2021 14:50:42 ACV0PFEINFP6000  Michaela Data Entry: Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918881
Page 182 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00) Mountain
Time (US & Canada)ODonoghue NO
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-27-2021 10:04:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-27-2021 10:04:43
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
RECOVERED/RESOLVE
DTranscription Error
Jan-27-2021 10:04:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Fall:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Jan-22-2021 14:51:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-22-2021 14:50:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Fall:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but AE
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918882
Page 183 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
End Date/Time is
present.
Jan-22-2021 14:50:42
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-22-2021 14:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918883
Page 184 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
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
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
Syncopal EpisodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
Jan/22/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NO
End Date Time:
Jan/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918884
Page 185 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData 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-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-24-2021
09:21:55
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query 2
: ClosedThe response to
If Other,
specify is
updated to
"cause
unknown".
Feb-23-2021
15:08:55
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2
: Answe
redsyncopal
episode related
to orthostatic
hypotension
listed as
additional AE
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918885
Page 186 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-23-2021
15:08:55
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Michaela ODonoghue Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ER
If
Oth
er,
spe
cify
:
ca
us
e
u
n
k
n
o
w
nsyncopal
episode related
to orthostatic
hypotension
listed as
additional AE
Feb-14-2021
23:30:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 2
: Opene
dPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918886
Page 187 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
[orthostatic
hypotension].
Any symptoms,
AEs or other
key data should
be collected on
the appropriate
page. Please
review and
update as
necessary.
Feb-11-2021
07:33:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query 1
: ClosedResponse
satisfies query
Feb-10-2021
15:44:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1
: Answe
redNew
Information
Feb-10-2021
15:44:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Michaela ODonoghue Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ERNew
Information
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) 
(4)
FDA-CBER-2021-5683-0918887
Page 188 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
If
Oth
er,
spe
cify
:
or
th
os
ta
ti
c
h
y
p
ot
e
ns
io
n
Feb-10-2021
08:26:47
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query 1
: Opene
dclinical: pls
advise as to
nature of non
drug treatment
that caused the
syncope.
Thanks
Feb-08-2021
16:42:09
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Michaela ODonoghue Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918888
Page 189 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
CON
CO
MIT
ANT
NO
N-D
RUG
TRE
ATM
ENT
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918889
Page 190 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-08-2021 16:42:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918890
Page 191 of 217
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
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
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
orthostatic hypotensionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
Jan/22/2021 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NO
End Date Time:
Jan/22/2021 10:00Initial Entry
6. Toxicity Grade:
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918891
Page 192 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Mar-03-2021 14:35:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed verified
Mar-02-2021 01:04:44
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened unable to verify
please upload
source with the PI
determination with
toxicity grading
and causality as
needed.
Feb-23-2021 15:13:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData 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-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918892
Page 193 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-23-2021 15:13:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
cause unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918893
Page 194 of 217
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-23-2021 15:13:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Michaela
ODonoghueData Entry:
NOInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918894
Page 195 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 15:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Jan/27/2021Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918895
Page 196 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-10-2021 11:09:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed noted and
confirmed
Feb-09-2021 13:39:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerQuery 1: Answered in Florence, under
source folder
titled "Form1"
Feb-07-2021 12:09:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened unable to verify
please upload
completed Form #
1
Jan-29-2021 15:35:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per local/national
recommendations and con
firmed to have received on
ly placebo at Vaccination
1/2Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918896
Page 197 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-29-2021 15:33:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-29-2021 15:33:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918897
Page 198 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 15:35:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Jan/29/2021Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918898
Page 199 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-29-2021 15:35:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
OBTAINED
Date Written Consent Obtai
ned
Jan/29/2021Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918899
Page 200 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-29-2021 15:36:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Jan/29/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-29-2021 15:36:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-29-2021 15:36:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918900
Page 201 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-29-2021 16:40:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-29-2021 16:40:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-29-2021 16:40:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Jan/29/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-29-2021 16:40:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-29-2021 16:40:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918901
Page 202 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-29-2021 16:40:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-29-2021 16:40:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-29-2021 16:40:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-29-2021 16:40:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
NOT DONEInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918902
Page 203 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 16:41:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 16:41:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 16:41:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 16:41:10
(UTC-07:00) Mountain
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.
Jan-29-2021 16:41:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 16:41:23 ACV0PFEINFP6000  Emily Data Entry: Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918903
Page 204 of 217
***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: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00) Mountain
Time (US & Canada)Anglemyer Sample ID: BNZPCY
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 16:41:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BNZPCYInitial Entry
5.b
Date Location User Value Reason
Jan-29-2021 16:48:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sample ID: BNVX4JInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-29-2021 16:48:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BNVX4JInitial Entry
5.c
Date Location User Value Reason
Jan-29-2021 16:48:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sample ID: BNVX4KInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-29-2021 16:48:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BNVX4KInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918904
Page 205 of 217
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 16:42:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 16:42:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 16:57:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 16:42:14
(UTC-07:00) Mountain
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.
Jan-29-2021 16:42:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 16:57:53 ACV0PFEINFP6000  Emily Data Entry: Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918905
Page 206 of 217
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00) Mountain
Time (US & Canada)Anglemyer Sample ID: BNZPCW
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 16:57:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BNZPCWInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918906
Page 207 of 217
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Jan/29/2021 15:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918907
Page 208 of 217
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-29-2021 16:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YESInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918908
Page 209 of 217
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 14:39:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed verified
Mar-03-2021 08:24:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerQuery 1: Answered Changed data per
query
Mar-02-2021 00:38:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Unable to verify,
please upload
source as needed
Feb-19-2021 16:06:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Feb/19/2021Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918909
Page 210 of 217
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918910
Page 211 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Sponsor-Defined Id
entifier:Not Do
ne
Test:: Not Do
ne
Result:: Not Do
ne
Not Done:: Not Do
neInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-19-2021 16:07:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
Not DoneInitial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918911
Page 212 of 217
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-19-2021 16:12:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021 16:12:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021 16:28:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-19-2021 16:12:10
(UTC-07:00) Mountain
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.
Feb-19-2021 16:12:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
YES
Date of Collection:
Feb/19/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021 16:28:24 ACV0PFEINFP6000  Emily Data Entry: Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918912
Page 213 of 217
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00) Mountain
Time (US & Canada)Anglemyer Sample ID: BP1CD4
5.a Sample ID
Date Location User Value Reason
Feb-19-2021 16:28:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
BP1CD4Initial Entry
090177e196ae2fdd\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918913
Page 214 of 217
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681091 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-19-2021 16:28:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Emily
AnglemyerData Entry:
NOInitial Entry
2. Treatment Name
Date Location Use
…[truncated]