Document text
Page 1 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837066
Page 2 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837067
Page 3 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12611006]
2.Birth Date: /1972
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837068
Page 4 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837069
Page 5 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837070
Page 6 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837071
Page 7 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vasectomy]
Start Date: Jun/15/2013
Ongoing: NO
End Date:
Jun/15/2013
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hydrocele Repair]
Start Date: Jun/15/2009
Ongoing: NO
End Date:
Jun/15/2009
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hydrocele repair ]
Start Date: Jun/15/2009
Ongoing: NO
End Date:
Jun/15/2009
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rash to antibiotics of unclear type]
Start Date: Jun/15/2017
Ongoing: YES
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837072
Page 8 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [92.9]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [32.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837073
Page 9 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [68448]
3.Randomization Group: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837074
Page 10 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8P95]
5.bSample ID [BP8P96]
5.cSample ID [BP8P97]
5.dSample ID [BLFVM0]
5.eSample ID [BLFVM1]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837075
Page 11 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8P94]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837076
Page 12 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 14:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837077
Page 13 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837078
Page 14 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837079
Page 15 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837080
Page 16 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BP8PHT]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837081
Page 17 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/17/2020 14:38
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
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837082
Page 18 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837083
Page 19 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BP8PLF]
5.bSample ID [BLFVVG]
5.cSample ID [BLFVVF]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837084
Page 20 of 184
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837085
Page 21 of 184
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837086
Page 22 of 184
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837087
Page 23 of 184
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837088
Page 24 of 184
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837089
Page 25 of 184
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837090
Page 26 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837091
Page 27 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837092
Page 28 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837093
Page 29 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837094
Page 30 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837095
Page 31 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837096
Page 32 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837097
Page 33 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837098
Page 34 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837099
Page 35 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837100
Page 36 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837101
Page 37 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837102
Page 38 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837103
Page 39 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837104
Page 40 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
1. DELETED ADVERS
E EVENT
1 Injection site reaction Aug/28/202
0 03:00 NO
End Date Time:
Aug/30/2020 21
:00
Repeating
Pages
2. ADVERS
E EVENT
2 Lip Abscess Sep/23/202
0 UNK:UN
K NO
End Date Time:
Oct/1/2020 UN
K:UNK
Repeating
Pages
3. ADVERS
E EVENT
3 Lip cellulitis Sep/23/202
0 UNK:UN
K NO
End Date Time:
Oct/1/2020 UN
K:UNK
Repeating
Pages
4. ADVERS
E EVENT
4 Hypersensitivity to antibiotics Sep/26/202
0 UNK:UN
K NO
End Date Time:
Sep/27/2020 U
NK:UNK
Repeating
Pages
5. ADVERS
E EVENT
5 DIFFUSE MYALGIA - ADVERS
E REACTION TO VACCINATIO
N 1 Aug/28/202
0 03:00 NO
End Date Time:
Aug/30/2020 21
:00
Repeating
Pages
6. ADVERS
E EVENT
6 CHILLS - ADVERSE REACTIO
N TO VACCINATION 1 Aug/28/202
0 03:00 NO
End Date Time:
Aug/30/2020 21
:00
Repeating
Pages
7. ADVERS
E EVENT
7 HEADACHE - ADVERSE REA
CTION TO VACCINATION 1 Aug/28/202
0 03:00 NO
End Date Time:Repeating
Pages
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837105
Page 41 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
Aug/30/2020 21
:00
8. DELETED ADVERS
E EVENT
8 Myalgias Aug/28/202
0 03:00 NO
End Date Time:
Aug/30/2020 21
:00
Repeating
Pages
9. DELETED ADVERS
E EVENT
9 Chills Aug/28/202
0 03:00 NO
End Date Time:
Aug/30/2020 21
:00
Repeating
Pages
10. DELETED ADVERS
E EVENT
10 Headache Aug/28/202
0 03:00 NO
End Date Time:
Aug/30/2020 21
:00
Repeating
Pages
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837106
Page 42 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Injection site reaction ]
4.Start Date Time: Aug/28/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 21:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837107
Page 43 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837108
Page 44 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Lip Abscess]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/1/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837109
Page 45 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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:
[unrelated medical condition]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[2020403622]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837110
Page 46 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Lip cellulitis]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/1/2020 UNK:UNK
6.Toxicity Grade: 3
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
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837111
Page 47 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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:
[Unrelated medical condition]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[2020403622]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837112
Page 48 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hypersensitivity to antibiotics]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/27/2020 UNK:UNK
6.Toxicity Grade: 3
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
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837113
Page 49 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[2020403690]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837114
Page 50 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[DIFFUSE MYALGIA - ADVERSE REACTION TO VACCINATION 1]
4.Start Date Time: Aug/28/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 21:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837115
Page 51 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837116
Page 52 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[CHILLS - ADVERSE REACTION TO VACCINATION 1]
4.Start Date Time: Aug/28/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 21:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837117
Page 53 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837118
Page 54 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[HEADACHE - ADVERSE REACTION TO VACCINATION 1]
4.Start Date Time: Aug/28/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 21:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837119
Page 55 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837120
Page 56 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Myalgias]
4.Start Date Time: Aug/28/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 21:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837121
Page 57 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837122
Page 58 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Aug/28/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 21:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837123
Page 59 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837124
Page 60 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache ]
4.Start Date Time: Aug/28/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 21:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837125
Page 61 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837126
Page 62 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837127
Page 63 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837128
Page 64 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837129
Page 65 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837130
Page 66 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837131
Page 67 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837132
Page 68 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837133
Page 69 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837134
Page 70 of 184
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837135
Page 71 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837136
Page 72 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837137
Page 73 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837138
Page 74 of 184
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837139
Page 75 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837140
Page 76 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837141
Page 77 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837142
Page 78 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837143
Page 79 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837144
Page 80 of 184
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837145
Page 81 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/31/2020
2.Erroneous Visit
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837146
Page 82 of 184
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837147
Page 83 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/31/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837148
Page 84 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837149
Page 85 of 184
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837150
Page 86 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837151
Page 87 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837152
Page 88 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sandra Lord Approved Feb-25-2021 10:59:55 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SandraLord, 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.
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837153
Page 89 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-27-2020 13:51:17 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837154
Page 90 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sandra Lord Approved Feb-25-2021 10:59:55 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SandraLord, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-24-2021 12:44:11 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sandra Lord Approved Jan-25-2021 12:24:42 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SandraLord, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-25-2021 11:08:30 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837155
Page 91 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Approved Jan-20-2021 14:38:34 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-05-2021 15:50:38 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-03-2020 09:36:19 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-02-2020 09:29:59 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-27-2020 16:09:02 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(6)
(b) (6)
(b)
(6)
(b) (6)
(b)
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837156
Page 92 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-22-2020 09:23:06 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-21-2020 16:07:50 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
(b) (6)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837157
Page 93 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 13:48:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 13:48:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837158
Page 94 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 13:48:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837159
Page 95 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 13:48:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12611006Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 13:48:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 13:50:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 13:50:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 13:50:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837160
Page 96 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 13:51:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837161
Page 97 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 13:51:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 13:51:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 13:51:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837162
Page 98 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 17:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:vasectomy
Start Date: Jun/15/2013
Ongoing: NO
End Date:
Jun/15/20
13Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:03:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 17:03:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
vasectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 17:03:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/15/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 17:03:13
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837163
Page 99 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) End Date:
Jun/15/2013
1.b
Date Location User Value Reason
Aug-27-2020 17:04:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Hydrocele Re
pair
Start Date: Jun/15/2009
Ongoing: NO
End Date:
Jun/15/200
9Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837164
Page 100 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:04:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 17:04:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Hydrocele RepairInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 17:04:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/15/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 17:04:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/15/2009Initial Entry
1.c
Date Location User Value Reason
Aug-27-2020 17:28:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:3
Medical History
Term:hydrocele re
pair
Start Date: Jun/15/2009Transcription Error
(DELETED)
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837165
Page 101 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: NO
End Date:
Jun/15/20
09
Aug-27-2020 17:18:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:hydrocele re
pair
Start Date: Jun/15/2009
Ongoing: NO
End Date:
Jun/15/20
09Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837166
Page 102 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:28:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Transcription Error
(DELETED)
Aug-27-2020 17:18:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 17:28:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hydrocele repairTranscription Error
(DELETED)
Aug-27-2020 17:18:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hydrocele repairInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-27-2020 17:28:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/15/2009Transcription Error
(DELETED)
Aug-27-2020 17:18:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/15/2009Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020 17:28:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/15/2009Transcription Error
(DELETED)
Aug-27-2020 17:18:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837167
Page 103 of 184
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jun/15/2009
1.d
Date Location User Value Reason
Aug-27-2020 17:31:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Rash to antibiotics
of unclear type
Start Date: Jun/15/2017
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:31:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 17:31:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Rash to antibiotics of unclear typ
eInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-27-2020 17:31:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/15/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-27-2020 17:31:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837168
Page 104 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
92.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.9Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837169
Page 105 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.5
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 17:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837170
Page 106 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020 17:37:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 17:37:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
68448Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837171
Page 107 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 13:58:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 13:58:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 13:59:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 13:58:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 13:58:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 13:59:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8P95Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837172
Page 108 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 13:59:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8P95Initial Entry
5.b
Date Location User Value Reason
Aug-27-2020 13:59:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8P96Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 13:59:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8P96Initial Entry
5.c
Date Location User Value Reason
Aug-27-2020 13:59:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8P97Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 13:59:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8P97Initial Entry
5.d
Date Location User Value Reason
Aug-27-2020 13:59:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFVM0Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837173
Page 109 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 13:59:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLFVM0Initial Entry
5.e
Date Location User Value Reason
Aug-27-2020 13:59:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFVM1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 13:59:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLFVM1Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837174
Page 110 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 13:59:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 13:59:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 14:00:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 13:59:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 13:59:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 14:00:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8P94Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837175
Page 111 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 14:00:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8P94Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837176
Page 112 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020 14:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837177
Page 113 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-27-2020 17:37:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837178
Page 114 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020 17:37:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837179
Page 115 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 13:48:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837180
Page 116 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 13:48:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 13:48:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 13:48:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 13:48:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 13:48:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837181
Page 117 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-17-2020 13:48:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837182
Page 118 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 13:48:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 13:48:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 13:48:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 13:48:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 13:48:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 13:48:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8PHTInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837183
Page 119 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 13:48:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8PHTInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837184
Page 120 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 14:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837185
Page 121 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-17-2020 14:43:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837186
Page 122 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 05:46:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-19-2020 11:57:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated eot
Oct-19-2020 04:35:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Patient
completed the
treatment phase and
reached at Visit 3.
Kindly consider to
update EOT form
with matching V3
date or else clarify.
Thank you.
Oct-15-2020 13:09:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837187
Page 123 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 13:09:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 13:09:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 13:09:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 13:09:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 13:09:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 13:09:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8PLFInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837188
Page 124 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 13:09:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8PLFInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 13:10:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFVVGInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 13:10:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLFVVGInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 13:10:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLFVVFInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 13:10:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLFVVFInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837189
Page 125 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020 11:57:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 11:57:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 11:57:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837190
Page 126 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-26-2020 11:54:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Changed
Information
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837191
Page 127 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837192
Page 128 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837193
Page 129 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837194
Page 130 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837195
Page 131 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837196
Page 132 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837197
Page 133 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-26-2020 11:55:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Already
recorded
previously.
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837198
Page 134 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-26-2020 11:55:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Already
recorded
previously.
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837199
Page 135 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-26-2020 11:55:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Already
recorded
previously.
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837200
Page 136 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 13:26:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-26-2020 11:54:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Oct-23-2020 12:42:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened GPD CLIN: Please
specify the symptom
of the injection site
reaction in the
verbatim term.
Additional
symptoms should be
documented as
separate AE terms.
Oct-23-2020 12:42:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Reissued using
standardized text.
Oct-22-2020 01:07:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please update the
event term in the
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837201
Page 137 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
CRF specify the type
of injection site
reaction. For
example, ‘injection
site pain’ or
‘injection site
redness’ or ‘injection
site swelling’.
Oct-21-2020 06:57:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY:
Please update the
event term in the
CRF specify the type
of injection site
reaction. For
example, ‘injection
site pain’ or
‘injection site
redness’ or ‘injection
site swelling’.
Sep-02-2020 16:52:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection site reactionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-10-2020 01:47:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Sep-09-2020 16:02:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-09-2020 16:02:23
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NONew Information
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837202
Page 138 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada) End Date Time:
Aug/30/2020 21:00
Sep-08-2020 08:53:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY:
Please review if this
event 'Injection site
reaction' remains
ongoing or if an
update to this field
and outcome status
can be entered.
Sep-02-2020 16:52:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837203
Page 139 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-09-2020 16:03:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-09-2020 16:03:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Sep-09-2020 16:02:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Injection site
reaction : Response to
"What was the
outcome of this
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837204
Page 140 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-02-2020 16:52:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-02-2020 16:52:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837205
Page 141 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Lip AbscessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/1/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837206
Page 142 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 03:06:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-17-2020 07:04:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON: Lip
Abscess(Onset
date:23Sep2020) 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
Oct-16-2020 15:49:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Lip Abscess:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-16-2020 15:49:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NO
Did this serious event result in dInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837207
Page 143 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020 01:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-20-2020 15:49:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-20-2020 15:49:02
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT RELATEDNew Information
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837208
Page 144 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
unrelated medical conditio
n
Oct-19-2020 04:10:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "If Not Related
to study
treatment(s), this
event is due to is
reported as "Other",
however specify is
missing? kindly
review and update.
Oct-16-2020 15:49:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific TimeACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837209
Page 145 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 15:49:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-19-2020 03:06:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020403622Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837210
Page 146 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Lip cellulitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/1/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837211
Page 147 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 03:09:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-17-2020 07:04:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON: Lip
cellulitis(Onset
date:23Sep2020) 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
Oct-16-2020 15:54:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Lip cellulitis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-16-2020 15:54:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NO
Did this serious event result in dInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837212
Page 148 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us 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
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020 02:07:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-20-2020 15:49:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-20-2020 15:49:20
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT RELATEDNew Information
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837213
Page 149 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Unrelated medical conditio
n
Oct-19-2020 04:10:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "If Not Related
to study
treatment(s), this
event is due to is
reported as "Other",
however specify is
missing? kindly
review and update.
Oct-16-2020 15:54:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 15:54:32
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOTranscription Error
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837214
Page 150 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
Oct-16-2020 15:54:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 15:54:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-19-2020 03:09:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020403622Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837215
Page 151 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Hypersensitivity to antibioticsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-22-2020 21:06:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-22-2020 09:23:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Oct-22-2020 09:23:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/26/2020 UNK:UNKChanged Information
Oct-22-2020 04:05:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020403690
Oct-16-2020 15:55:39
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
Sep/27/2020 UNK:UNKInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837216
Page 152 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/27/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 11:16:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Thank you!
Oct-27-2020 08:53:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Methylprednisolone was
given as IV infusion for
only 1 day during ED
visit.
Oct-21-2020 19:19:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened CLINICAL_ Subject
received
Methylprednisolone
while in the emergency
room, per protocol if the
steroids (>20mg) was
given for more than 14
days – that needs to be
added to the con med
CRF. Please
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837217
Page 153 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
revise/update
accordingly. Thank you.
Oct-19-2020 03:10:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-17-2020 07:09:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:Hypersensitivity
to antibiotics(Onset
date:27Sep2020) 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
Oct-16-2020 15:55:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Hypersensitivity
to antibiotics: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Oct-16-2020 15:55:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result
in persistent or significant di
sability/incapacity?Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837218
Page 154 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious 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
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020 01:34:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-20-2020 15:44:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-20-2020 15:44:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
CONCOMITANT DRUG TR
EATMENTNew Information
Oct-19-2020 04:11:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "If Not Related
to study
treatment(s), this
event is due to is
reported as "Other",
however specify is
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837219
Page 155 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
missing? kindly
review and update.
Oct-16-2020 15:55:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-21-2020 02:08:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-20-2020 15:46:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-20-2020 15:46:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESChanged
Information
Oct-19-2020 04:11:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Was a
Concomitant
Medication given?"
is missing. Kindly
review and update.
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837220
Page 156 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 15:55:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-19-2020 03:10:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020403690Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837221
Page 157 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-02-2020
10:13:34
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse satisfies
query
Nov-02-2020
09:29:59
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answere
dNew Information
Nov-02-2020
09:29:59
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
DIFFUS
E MYAL
GIA - A
DVERS
E REAC
TION T
O VACC
INATIO
N 1New Information
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837222
Page 158 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-02-2020
01:14:43
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Reissued
:OpenedCLINQUERY: Please
update the CRF to
specify anatomical
site in the event term.
If generalized, please
state as such. Thank
you.
Oct-30-2020
18:44:31
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Reissued
:Candida
teCLINQUERY: Please
update the CRF to
specify anatomical
site in the event term.
If generalized, please
state as such. Thank
you.
Oct-30-2020
16:02:29
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Answere
dPage frozen. please
unfreeze to update.
Oct-30-2020
13:40:38
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedCLINQUERY: Please
update the CRF to
specify anatomical
site in the event term.
If generalized, please
state as such. Thank
you.
Oct-30-2020
12:19:32
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Candidat
eCLINQUERY: Please
update the CRF to
specify anatomical
site in the event term.
If generalized, please
state as such. Thank
you.
Oct-19-2020
14:40:11
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
ClosedDiscrepancy has been
closed.
Oct-19-2020
12:06:26
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dTranscription Error
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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)
FDA-CBER-2021-5683-0837223
Page 159 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time
(US &
Canada)
Oct-19-2020
12:06:26
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
MYALG
IA - AD
VERSE
REACTI
ON TO
VACCIN
ATION 1Transcription Error
Oct-17-2020
00:08:51
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
OpenedClarify MYALGIA
SECONDARY TO
VAX1 as follows...Are
you reporting
MYALGIA -
ADVERSE
REACTION TO
VACCINATION 1?
Or
POSTPROCEDURAL
MYALGIA? Or other?
Please update the
verbatim term to
clarify and spell out
VAX1. Thank you.
Oct-16-2020
15:56:37
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
myalgia
secondar
y to vax1Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837224
Page 160 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 21:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837225
Page 161 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 15:56:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837226
Page 162 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020
14:39:45
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: C
losedDiscrepancy has been
closed.
Oct-19-2020
12:06:49
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredTranscription Error
Oct-19-2020
12:06:49
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
CHILLS -
ADVERSE
REACTIO
N TO VAC
CINATIO
N 1Transcription Error
Oct-16-2020
22:46:53
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: O
penedClarify CHILL
SECONDARY TO
VAX1 as follows...Are
you reporting CHILL
- ADVERSE
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837227
Page 163 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
REACTION TO
VACCINATION 1?
Or
POSTPROCEDURAL
CHILLS? Or other?
Please update the
verbatim term to
clarify and spell out
VAX1. Thank you.
Oct-16-2020
15:57:11
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Chill secon
dary to vax
1Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 21:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837228
Page 164 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837229
Page 165 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 15:57:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837230
Page 166 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020
14:40:27
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: C
losedDiscrepancy has been
closed.
Oct-19-2020
12:07:09
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredTranscription Error
Oct-19-2020
12:07:09
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
HEADAC
HE - ADV
ERSE REA
CTION TO
VACCINA
TION 1Transcription Error
Oct-17-2020
00:09:08
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: O
penedClarify HEADACHE
SECONDARY TO
VAX1 as follows...Are
you reporting
HEADACHE -
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837231
Page 167 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
ADVERSE
REACTION TO
VACCINATION 1?
Or
POSTPROCEDURAL
HEADACHE ? Or
other? Please update
the verbatim term to
clarify and spell out
VAX1. Thank you.
Oct-16-2020
15:57:40
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Headache s
econdary to
vax1Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 21:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837232
Page 168 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837233
Page 169 of 184
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 15:57:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837234
Page 170 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MyalgiasInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 21:00Initial Entry
6. Toxicity Grade:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837235
Page 171 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837236
Page 172 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020 11:52:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837237
Page 173 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 21:00Initial Entry
6. Toxicity Grade:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837238
Page 174 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837239
Page 175 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020 11:53:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837240
Page 176 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/30/2020 21:00Initial Entry
6. Toxicity Grade:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837241
Page 177 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (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-2021-5683-0837242
Page 178 of 184
***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, Deleted, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020 11:54:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837243
Page 179 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-05-2021 15:50:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/31/2020Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837244
Page 180 of 184
***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
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-25-2021 11:08:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at V
accination 1/2Transcription Error
Jan-05-2021 15:50:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to retur
n for Vaccination 3 OR otherwise
not eligibleInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837245
Page 181 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-25-2021
00:29:47
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Feb-24-2021
12:44:11
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-24-2021
12:44:11
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Dec/3
1/202
0Transcription Error
Feb-23-2021
15:21:25
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7353152;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Jan-05-2021
15:50:38
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Dec/2
9/202
0Initial Entry
2. Primary Reason for Unblinding:
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0837246
Page 182 of 184
***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: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Jan-05-2021 15:50:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837247
Page 183 of 184
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-19-2020 11:57:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020 17:37:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-27-2020 13:51:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-19-2020 11:57:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Aug-27-2020 17:37:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-27-2020 13:51:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837248
Page 184 of 184
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason
Subject No: 12611006 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 16:07:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d86\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837249