Document text
Page 1 of 241
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930569
Page 2 of 241
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/13/2020
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930570
Page 3 of 241
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11221053]
2.Birth Date: /1965
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930571
Page 4 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930572
Page 5 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930573
Page 6 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930574
Page 7 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[atypical cardiomegaly]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Viral infection]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2010
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Reconstruction of left shoulder]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930575
Page 8 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Joint Debridement Left Knee]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[impingement surgery of right shoulder]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lack of cartilage, bilateral knees]
Start Date: UNK/UNK/2012
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Flat Feet]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930576
Page 9 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ADHD]
Start Date: UNK/UNK/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Familial Low White blood cell Count]
Start Date: UNK/UNK/2015
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Joint resurfacing of left knee]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[reduced ejection fraction]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930577
Page 10 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[eczema]
Start Date: UNK/UNK/1974
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cold sores]
Start Date: UNK/UNK/2001
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ingrown hair]
Start Date: UNK/UNK/1981
Ongoing: YES
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930578
Page 11 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930579
Page 12 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
2.Weight: [267.5]
3.Unit: LB
4.Height: [76.0]
5.Unit: in
6.Body Mass Index: [32.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930580
Page 13 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/13/2020
2.Randomization Number: [106126]
3.Randomization Group: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930581
Page 14 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJL42W]
5.bSample ID [BJV39L]
5.cSample ID [BJV39M]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930582
Page 15 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJL42X]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930583
Page 16 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/13/2020 14:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930584
Page 17 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930585
Page 18 of 241
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930586
Page 19 of 241
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930587
Page 20 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BJL45D]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930588
Page 21 of 241
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: Nov/4/2020 16:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930589
Page 22 of 241
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930590
Page 23 of 241
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJL45Y]
5.bSample ID [BJV3F7]
5.cSample ID [BJV3F8]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930591
Page 24 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930592
Page 25 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930593
Page 26 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930594
Page 27 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930595
Page 28 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930596
Page 29 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930597
Page 30 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930598
Page 31 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930599
Page 32 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930600
Page 33 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930601
Page 34 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930602
Page 35 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930603
Page 36 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930604
Page 37 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930605
Page 38 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930606
Page 39 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930607
Page 40 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryAE I
denti
fierAdverse EventStart Da
teIs the Adverse
Event Still On
goingForm Insta
nce
1. ADVE
RSE E
VENT 1 flare up of eczema Oct/20/2
020 UNK
:UNK NO
End Date Ti
me:
Nov/12/202
0 UNK:UN
K
Repeating
Pages
2. ADVE
RSE E
VENT 2 mild body itching-specific re
gion: lateral aspect of right fo
rearm and left side of neck Nov/8/20
20 UNK:
UNK NO
End Date Ti
me:
Nov/14/202
0 UNK:UN
K
Repeating
Pages
3. ADVE
RSE E
VENT 3 very mild fatigue Nov/8/20
20 UNK:
UNK NO
End Date Ti
me:
Nov/14/202
0 UNK:UN
K
Repeating
Pages
4. ADVE
RSE E
VENT 4 fatigue Nov/7/20
20 UNK:
UNK NO
End Date Ti
me:
Nov/12/202
0 UNK:UN
K
Repeating
Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930608
Page 41 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryAE I
denti
fierAdverse EventStart Da
teIs the Adverse
Event Still On
goingForm Insta
nce
5. DELETED ADVE
RSE E
VENT 5 worsening cold sore Jan/2/202
1 UNK:U
NK NO
End Date Ti
me:
Jan/6/2021
UNK:UNK
Repeating
Pages
6. DELETED ADVE
RSE E
VENT 6 worsening ingrown hair Jan/8/202
1 UNK:U
NK NO
End Date Ti
me:
Jan/10/2021
UNK:UNK
Repeating
Pages
7. ADVE
RSE E
VENT 7 Infected laceration right thum
b Jan/2/202
1 UNK:U
NK NO
End Date Ti
me:
Jan/4/2021
UNK:UNK
Repeating
Pages
8. ADVE
RSE E
VENT 8 Swollen lymph node right ja
w Dec/31/2
020 UNK
:UNK NO
End Date Ti
me:
Jan/2/2021
UNK:UNK
Repeating
Pages
9. ADVE
RSE E
VENT 9 Tender lymph node right jaw Dec/31/2
020 UNK
:UNK NO
End Date Ti
me:
Jan/2/2021
UNK:UNKRepeating
Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930609
Page 42 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryAE I
denti
fierAdverse EventStart Da
teIs the Adverse
Event Still On
goingForm Insta
nce
10. ADVE
RSE E
VENT 10 Cellulitis groin Dec/15/2
020 UNK
:UNK NO
End Date Ti
me:
Dec/25/202
0 UNK:UN
K
Repeating
Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930610
Page 43 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[flare up of eczema]
4.Start Date Time: Oct/20/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/12/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930611
Page 44 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[exacerbation of prior medical condition]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930612
Page 45 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[mild body itching-specific region: lateral aspect of right forearm and
left side of neck]
4.Start Date Time: Nov/8/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/14/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930613
Page 46 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[hx of eczema]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930614
Page 47 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[very mild fatigue]
4.Start Date Time: Nov/8/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/14/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930615
Page 48 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930616
Page 49 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[fatigue]
4.Start Date Time: Nov/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/12/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930617
Page 50 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930618
Page 51 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** 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: [5]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[worsening cold sore ]
4.Start Date Time: Jan/2/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/6/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930619
Page 52 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due
to:
OTHER
If Other, specify:
[Frequently experiences cold sores ]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES Comments
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[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930620
Page 53 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** 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: [6]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[worsening ingrown hair ]
4.Start Date Time: Jan/8/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/10/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930621
Page 54 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Frequently experiences ingrown hair ]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930622
Page 55 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Infected laceration right thumb]
4.Start Date Time: Jan/2/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/4/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930623
Page 56 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due
to:
OTHER
If Other, specify:
[accidental self-inflicted injury]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES Comments
12.Was a Non-Drug Treatment
given?YES Comments
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[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930624
Page 57 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Swollen lymph node right jaw]
4.Start Date Time: Dec/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/2/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930625
Page 58 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[states lymph nodes often swell prior to cold sore eruption]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930626
Page 59 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Tender lymph node right jaw]
4.Start Date Time: Dec/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/2/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930627
Page 60 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[states lymph nodes often tender prior to cold sore eruption]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930628
Page 61 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[Cellulitis groin]
4.Start Date Time: Dec/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930629
Page 62 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due
to:
OTHER
If Other, specify:
[reports use of public hot tub prior to cellulitis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES Comments
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[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930630
Page 63 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryMedication
ErrorStart D
ateIs the medication error S
till OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930631
Page 64 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930632
Page 65 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930633
Page 66 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: //
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930634
Page 67 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930635
Page 68 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930636
Page 69 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930637
Page 70 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930638
Page 71 of 241
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930639
Page 72 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930640
Page 73 of 241
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930641
Page 74 of 241
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930642
Page 75 of 241
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930643
Page 76 of 241
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930644
Page 77 of 241
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930645
Page 78 of 241
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930646
Page 79 of 241
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930647
Page 80 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930648
Page 81 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930649
Page 82 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930650
Page 83 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930651
Page 84 of 241
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930652
Page 85 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930653
Page 86 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930654
Page 87 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930655
Page 88 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930656
Page 89 of 241
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930657
Page 90 of 241
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930658
Page 91 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/2/2020
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930659
Page 92 of 241
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930660
Page 93 of 241
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930661
Page 94 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-14-2020 09:04:09 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930662
Page 95 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-11-2021 11:35:27 (UTC-05:00)
Eastern Time (US & Canada)Please Unfreeze LOG AE CRF to
address query
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930663
Page 96 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
11Feb-02-2021 13:27:51 (UTC-05:00)
Eastern Time (US & Canada)topical bacitracin
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930664
Page 97 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
11Feb-02-2021 15:36:14 (UTC-05:00)
Eastern Time (US & Canada)topical bacitracin
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930665
Page 98 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
12Feb-04-2021 16:02:22 (UTC-05:00)
Eastern Time (US & Canada)Warm compress
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930666
Page 99 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
11Feb-02-2021 13:34:12 (UTC-05:00)
Eastern Time (US & Canada)cipro 500mg twice daily for 10 days
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930667
Page 100 of 241
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-29-2021 12:09:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Margaret
Tiktin Approved Jan-25-2021 08:54:12 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MargaretTiktin, 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.
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930668
Page 101 of 241
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-14-2020
09:03:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-14-2020
09:03:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930669
Page 102 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020
09:03:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Oct/13/2020Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930670
Page 103 of 241
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020
09:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11221053Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020
09:03:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020
09:03:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-14-2020
09:03:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANI
SH ORIGINInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930671
Page 104 of 241
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020
09:03:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN
AMERICANInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930672
Page 105 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
09:04:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930673
Page 106 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-14-2020
09:04:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
09:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
09:04:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930674
Page 107 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020
09:23:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:atypical car
diomegaly
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020
09:23:14
(UTC-05:00) Eastern
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
Oct-14-2020
09:23:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
atypical cardiomegalyInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930675
Page 108 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-14-2020
09:23:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-14-2020
09:23:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-15-2020
15:18:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:2
Medical Hi
story Term
:Viral infect
ion
Start Date: UNK/UNK
/2008
Ongoing: NO
End Date:
UNK/U
NK/201
0changed per
query
Oct-15-2020
09:34:45
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num2Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930676
Page 109 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada) ber:
Medica
l Histor
y Term:Viral infection t
hat affected eje
ction fraction
Start D
ate:UNK/UNK/20
08
Ongoin
g:NO
End Date:
UNK/UNK/
2010
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930677
Page 110 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:34:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Oct-15-2020
21:55:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Oct-15-2020
15:18:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dchanged per
query
Oct-15-2020
15:18:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Viral i
nfecti
onchanged per
query
Oct-15-2020
14:09:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedMultiple
concepts in
the term
VIRAL
INFECTION
THAT
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0930678
Page 111 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
AFFECTED
EJECTION
FRACTION.
Split the
term into
VIRAL
INFECTION
and
EJECTION
FRACTION
and submit
separately.
Thank you.
Oct-15-2020
09:34:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Viral i
nfecti
on tha
t affec
ted ej
ection
fracti
onInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-15-2020
09:34:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930679
Page 112 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-15-2020
09:34:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.c
Date Location User Value Reason
Oct-15-2020
09:35:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Reconstruction
of left shoulder
Start Date
:UNK/UNK/19
90
Ongoing: NO
End Date:
UNK/UNK/
1990Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930680
Page 113 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:35:38
(UTC-05:00) Eastern
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
Oct-15-2020
09:35:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Reconstruction of left sh
oulderInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-15-2020
09:35:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-15-2020
09:35:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.d
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930681
Page 114 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-16-2020
08:34:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:4
Medical
History
Term:Joint Debrid
ement Left K
nee
Start Dat
e:UNK/UNK/
2014
Ongoing: NO
End Date:
UNK/UN
K/2014New
Information
Oct-15-2020
09:36:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Removal of
debris of joi
nt
Start Dat
e:UNK/UNK/
2014
Ongoing: NO
End Date:
UNK/UN
K/2014Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930682
Page 115 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:36:28
(UTC-05:00) Eastern
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
Oct-16-2020
08:34:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Joint Debridement Left
KneeNew
Information
Oct-15-2020
09:36:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Removal of debris of joi
ntInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-15-2020
09:36:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-15-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930683
Page 116 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
09:36:28
(UTC-05:00)
Eastern Time (US &
Canada)NO
End Date:
UNK/UNK/2014
1.e
Date Location User Value Reason
Oct-15-2020
09:37:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History T
erm:impingement sur
gery of right sho
ulder
Start Dat
e:UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930684
Page 117 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:37:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020
09:37:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
impingement surgery of r
ight shoulderInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-15-2020
09:37:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-15-2020
09:37:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.f
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930685
Page 118 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-16-2020
08:37:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:6
Medical
History T
erm:lack of carti
lage, bilater
al knees
Start Dat
e:UNK/UNK/
2012
Ongoing: YESTranscription
Error
Oct-15-2020
09:38:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History
Term:no cartilage
under both k
nee caps
Start Dat
e:UNK/UNK/
2012
Ongoing: YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930686
Page 119 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.f Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:38:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
08:37:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
lack of cartilage, bilater
al kneesTranscription
Error
Oct-15-2020
09:38:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
no cartilage under both
knee capsInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-15-2020
09:38:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-15-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930687
Page 120 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
09:38:34
(UTC-05:00)
Eastern Time (US &
Canada)YES
1.g
Date Location User Value Reason
Oct-15-2020
09:39:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Flat Feet
Start Date: UNK/U
NK/2018
Ongoing: YESTranscription
Error
Oct-15-2020
09:38:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:ADHD
Start Date: UNK/U
NK/2018
Ongoing: YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930688
Page 121 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.g Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:38:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020
09:39:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Flat FeetTranscription
Error
Oct-15-2020
09:38:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ADHDInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-15-2020
09:38:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-15-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930689
Page 122 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
09:38:56
(UTC-05:00)
Eastern Time (US &
Canada)YES
1.h
Date Location User Value Reason
Oct-15-2020
09:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:ADHD
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930690
Page 123 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.h Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020
09:56:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ADHDInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-15-2020
09:56:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930691
Page 124 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.h Ongoing:
Date Location User Value Reason
Oct-15-2020
09:56:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-16-2020
08:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/M
H Numb
er:9
Medical
History
Term:Familial Lo
w White blo
od cell Coun
t
Start Da
te:UNK/UNK/
2015
Ongoing
:YESTranscription
Error
Oct-15-2020
09:57:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical
History T
erm:Familial Lo
w White C
ount
Start Dat
e:UNK/UNK
/2015
Ongoing: YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930692
Page 125 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.i Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
08:39:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Familial Low White blo
od cell CountTranscription
Error
Oct-15-2020
09:57:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Familial Low White Co
untInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-15-2020
09:57:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-15-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930693
Page 126 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
09:57:22
(UTC-05:00)
Eastern Time (US &
Canada)YES
1.j
Date Location User Value Reason
Oct-16-2020
08:40:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:10
Medical
History T
erm:Joint resurfa
cing of left k
nee
Start Dat
e:UNK/UNK/
2014
Ongoing: NO
End Date:
UNK/UN
K/2014New
Information
Oct-15-2020
09:58:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical Hi
story Term
:Resurfacin
g of joint
Start Date: UNK/UNK
/2014Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930694
Page 127 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: NO
End Date
:
UNK/U
NK/201
4
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930695
Page 128 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.j Line/MH Number:
Date Location User Value Reason
Oct-15-2020
09:58:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
08:40:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Joint resurfacing of left
kneeNew
Information
Oct-15-2020
09:58:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Resurfacing of jointInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-15-2020
09:58:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-15-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930696
Page 129 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
09:58:07
(UTC-05:00)
Eastern Time (US &
Canada)NO
End Date:
UNK/UNK/2014
1.k
Date Location User Value Reason
Oct-16-2020
08:42:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:11
Medical
History T
erm:reduced eje
ction fractio
n
Start Dat
e:UNK/UNK/
2008
Ongoing: NO
End Date:
UNK/U
NK/2010New
Information
Oct-16-2020
08:24:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:reduced eje
ction fracti
on
Start Date
:UNK/UNK
/2008
Ongoing: YESTranscription
Error
Oct-15-2020
15:19:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:11Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930697
Page 130 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical His
tory Term:ejection f
raction
Start Date: UNK/U
NK/2008
Ongoing: YES
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930698
Page 131 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.k Line/MH Number:
Date Location User Value Reason
Oct-15-2020
15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-12-2020
16:45:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-12-2020
13:21:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Nov-09-2020
14:14:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
AE - FLARE UP
OF ECZEMA -
Causality is
"exacerbation of
prior medical
condition".
Therefore, please
update the
Medical History
CRF with the
applicable
Pre-Existing
Condition.
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930699
Page 132 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-09-2020
11:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY:
AE - FLARE UP
OF ECZEMA -
Causality is
"exacerbation of
prior medical
condition".
Therefore, please
update the
Medical History
CRF with the
applicable
Pre-Existing
Condition.
Oct-16-2020
08:24:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
reduced ejection fract
ionTranscription
Error
Oct-15-2020
15:19:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ejection fractionInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-15-2020
15:19:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.k Ongoing:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930700
Page 133 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-16-2020
08:42:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2010New
Information
Oct-15-2020
15:19:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Nov-12-2020
13:21:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:eczema
Start Date: UNK/UN
K/1974
Ongoing: YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930701
Page 134 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.l Line/MH Number:
Date Location User Value Reason
Nov-12-2020
13:21:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-10-2021
10:52:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-10-2021
08:53:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered lines 1.m and 1.n
were added to
med hx to
document the
pre-existing
conditions
Feb-09-2021
14:57:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Per query
responses for
Adverse Event
Records 5 and 6,
please update the
Medical History
CRF and add
two records for
the Pre-Existing
Conditions.
Feb-08-2021
13:30:42ACV0PFEINFP6000 Query 1: Candidate CLINQUERY:
Per query
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930702
Page 135 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00)
Eastern Time (US
& Canada)responses for
Adverse Event
Records 5 and 6,
please update the
Medical History
CRF and add
two records for
the Pre-Existing
Conditions.
Nov-12-2020
13:21:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
eczemaInitial Entry
1.l Start Date:
Date Location User Value Reason
Nov-12-2020
13:21:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1974Initial Entry
1.l Ongoing:
Date Location User Value Reason
Nov-12-2020
13:21:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Feb-09-2021
13:15:21ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930703
Page 136 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)Line/MH Nu
mber:13
Medical Histo
ry Term:cold sores
Start Date: UNK/UN
K/2001
Ongoing: YES
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930704
Page 137 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.m Line/MH Number:
Date Location User Value Reason
Feb-09-2021
13:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-09-2021
13:15:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
cold soresInitial Entry
1.m Start Date:
Date Location User Value Reason
Feb-09-2021
13:15:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.m Ongoing:
Date Location User Value Reason
Feb-09-2021
13:15:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930705
Page 138 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Feb-09-2021
13:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:14
Medical Histo
ry Term:ingrown h
air
Start Date: UNK/UN
K/1981
Ongoing: YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930706
Page 139 of 241
***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.n Line/MH Number:
Date Location User Value Reason
Feb-09-2021
13:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-09-2021
13:15:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ingrown hairInitial Entry
1.n Start Date:
Date Location User Value Reason
Feb-09-2021
13:15:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1981Initial Entry
1.n Ongoing:
Date Location User Value Reason
Feb-09-2021
13:15:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930707
Page 140 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-14-2020
09:05:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT kno
wn to be HIV POSITIVEInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930708
Page 141 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
267.5Initial Entry
3. Unit:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
76.0Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930709
Page 142 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
5. Unit:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.6Initial Entry
7.a
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:98.5
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930710
Page 143 of 241
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-14-2020
09:07:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930711
Page 144 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-14-2020
09:08:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-14-2020
09:08:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
106126Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930712
Page 145 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
08:56:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
08:56:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
08:56:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
08:56:40
(UTC-05:00)
Eastern 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.
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930713
Page 146 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-15-2020
08:56:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
08:56:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJL42WInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
08:56:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJL42WInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020
08:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJV39LInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930714
Page 147 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
08:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJV39LInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020
08:57:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJV39MInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
08:57:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJV39MInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930715
Page 148 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
08:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
08:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
09:00:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
08:57:50
(UTC-05:00)
Eastern 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.
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930716
Page 149 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-15-2020
08:57:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
09:00:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJL42XInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
09:00:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJL42XInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930717
Page 150 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020 14:05Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930718
Page 151 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020
09:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930719
Page 152 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-14-2020
09:08:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930720
Page 153 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-14-2020
09:09:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT COL
LECTED FOR THIS SU
BJECTInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930721
Page 154 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020
08:42:46
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/4/2020Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930722
Page 155 of 241
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-05-2020
08:44:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/4/2020Initial Entry
2.a
Date Location User Value Reason
Nov-05-2020
08:44:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:98.8
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-05-2020
08:44:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930723
Page 156 of 241
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-05-2020
08:44:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-05-2020
08:44:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-05-2020
08:44:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930724
Page 157 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020
08:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020
08:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020
08:45:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-05-2020
08:45:03
(UTC-05:00)
Eastern 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.
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930725
Page 158 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-05-2020
08:45:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020
08:45:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJL45DInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020
08:45:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJL45DInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930726
Page 159 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/4/2020 16:14Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930727
Page 160 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Anatomical Location:
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-05-2020
08:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930728
Page 161 of 241
***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, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-05-2020
08:43:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930729
Page 162 of 241
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-02-2020
16:28:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930730
Page 163 of 241
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-02-2020
16:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-02-2020
16:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-02-2020
16:37:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-02-2020
16:37:15
(UTC-05:00)
Eastern 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.
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930731
Page 164 of 241
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-02-2020
16:37:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/2/2020Initial Entry
5.a
Date Location User Value Reason
Dec-02-2020
16:37:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJL45YInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-02-2020
16:37:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJL45YInitial Entry
5.b
Date Location User Value Reason
Dec-02-2020
16:37:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJV3F7Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930732
Page 165 of 241
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Sample ID
Date Location User Value Reason
Dec-02-2020
16:37:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJV3F7Initial Entry
5.c
Date Location User Value Reason
Dec-02-2020
16:37:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJV3F8Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-02-2020
16:37:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BJV3F8Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930733
Page 166 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930734
Page 167 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930735
Page 168 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930736
Page 169 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930737
Page 170 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-16-2021
10:12:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Feb-16-2021
10:10:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Undeleted Transcription
Error
Feb-09-2021
13:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930738
Page 171 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-09-2021
13:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930739
Page 172 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Jan-29-2021 12:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930740
Page 173 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Jan-29-2021 12:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930741
Page 174 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Jan-29-2021 12:23:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930742
Page 175 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Jan-29-2021 12:38:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930743
Page 176 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-12-2021
16:11:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-12-2021
09:03:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Previously
reported AEs
were deleted
(worsening cold
sores and
worsening
ingrown hair)
after clarifying
with the subject
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0930744
Page 177 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
that these
intermittent
conditions
started before
study start. They
were not a
worsening just a
reoccurrence.
Feb-12-2021
01:50:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened DM: Per
Comment on
medical history
AE form in
unfrozen. Please
verify and
update data
accordingly.
Thank you.
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
flare up of eczemaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930745
Page 178 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-01-2020
12:16:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-01-2020
10:36:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Dec-01-2020
10:36:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/12/2020 UNK:
UNKChanged
Information
Nov-30-2020
12:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please determine
if this Adverse
Event is still
ONGOING as it
has been 41 days
since Onset Date.
Please update or
confirm.
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930746
Page 179 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern 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
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930747
Page 180 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US &
Canada)reatment(s), this event i
s due to:
OTHER
If Other, specify:
exacerbation of pri
or medical conditio
n
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930748
Page 181 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-01-2020
10:36:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-01-2020
10:36:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RE
SOLVEDChanged Information
Dec-01-2020
10:36:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE flare up of
eczema : Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/R
ESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020
14:16:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930749
Page 182 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00) Eastern
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
Dec-04-2020
14:17:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-04-2020
13:50:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Dec-04-2020
10:51:09
(UTC-05:00)ACV0PFEINFP6000 Query 1: Reissued:Ope
nedclin: Thank you,
but pls clarify.
AE still listed as
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930750
Page 183 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US &
Canada)'related', but
prior response
seems to indicate
it is attributed to
known hx of
eczema. Pls
review and
update causality
if appropriate.
Dec-03-2020
14:21:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-03-2020
14:21:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
mild body itching-speci
fic region: lateral aspect
of right forearm and lef
t side of neckNew Information
Dec-03-2020
14:12:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Reissued:Ope
nedDM has
unfrozen.
Dec-03-2020
12:34:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Upon follow up
with subject,
itching was on
lateral aspect of
right forearm
and on left side
of neck from
eczema flare.
Eczema is
already a
recorded AE.
Please unfreeze
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930751
Page 184 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
CRF to update
appropriately.
Dec-02-2020
08:56:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls
update AE term
to indicate if
'generalised' or
specify which
body parts
involved.
Confirm no
associated rash
or enter separate
AE for rash.
Thanks
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
mild body itchingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/8/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-30-2020
15:56:28
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930752
Page 185 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada)
Nov-30-2020
15:10:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-30-2020
15:10:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/14/2020 UNK:
UNKChanged
Information
Nov-30-2020
12:28:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please determine
if this Adverse
Event is still
ONGOING as it
has been 22 days
since Onset Date.
Please update or
confirm.
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930753
Page 186 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern 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
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-04-2020
13:49:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this event
is due to:
OTHER
If Other, specify:Changed
Information
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930754
Page 187 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
hx of eczema
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020
09:58:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930755
Page 188 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Nov-30-2020
15:10:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-30-2020
15:10:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VEDChanged
Information
Nov-30-2020
15:10:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE mild
body itching :
Response to
"What was the
outcome of this
adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020
09:57:51
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930756
Page 189 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada)
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930757
Page 190 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00) Eastern
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
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
very mild fatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/8/2020 UNK:UNKInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930758
Page 191 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-30-2020
15:56:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-30-2020
15:11:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-30-2020
15:11:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/14/2020 UNK:
UNKChanged
Information
Nov-30-2020
12:28:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please determine
if this Adverse
Event is still
ONGOING as it
has been 22 days
since Onset Date.
Please update or
confirm.
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930759
Page 192 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern 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
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930760
Page 193 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930761
Page 194 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-30-2020
15:11:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-30-2020
15:11:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VEDChanged
Information
Nov-30-2020
15:11:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE very mild
fatigue: Response
to "What was the
outcome of this
adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020
09:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930762
Page 195 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00) Eastern
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
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
fatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/7/2020 UNK:UNKInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930763
Page 196 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/12/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern 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
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern 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.
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930764
Page 197 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930765
Page 198 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-01-2020
16:16:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930766
Page 199 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021 12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-29-2021 12:09:12
(UTC-05:00) Eastern
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
Feb-02-2021
10:38:47
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
worsening cold sorechanged term
per query
Jan-29-2021
12:09:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
cold soreInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930767
Page 200 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-29-2021
12:39:32
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/2/2021 UNK:UNKTranscription
Error
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/2/2021 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-29-2021
12:40:07
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/6/2021 UNK:UNKTranscription
Error
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/6/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930768
Page 201 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
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
Feb-02-2021
13:53:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-02-2021
10:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-02-2021
10:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription
Error
Feb-01-2021
06:07:44ACV0PFEINFP6000 Query 1: Opened DM: Response to
'Is this AE the
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0930769
Page 202 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00)
Eastern Time (US
& Canada)result of Med
Error?' is YES,
however no
Medication Error
with
corresponding
AE is recorded
under
Medication Error
page. Kindly
review and
update as
appropriate, else
clarify.
Jan-29-2021
12:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021
11:09:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-16-2021
10:12:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Previously
reported AE was
deleted
(worsening cold
sores) after
clarifying with
the subject that
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930770
Page 203 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
this intermittent
condition started
before study
start. This was
not a worsening
just a
reoccurrence.
Feb-10-2021
09:59:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:Ope
nedclinical: pls
advise as to why
AE of worsening
cold sores was
deleted. Thanks
Feb-09-2021
13:14:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Feb-09-2021
12:10:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened clinical: Past hx
of cold sores has
not been added
to MedHx CRF.
Pls do so asap as
this form will be
re-locked soon.
Thanks
Feb-08-2021
13:29:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-07-2021
16:47:02
(UTC-05:00)ACV0PFEINFP6000 Query 1: Reissued:Ope
nedclinical: have
requested DM
unlock MedHx
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930771
Page 204 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Eastern Time (US
& Canada)CRF
Feb-05-2021
16:54:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered history of cold
sores predates
enrollment.
Please unfreeze
MedHx CRF to
be updated
appropriately.
Feb-02-2021
10:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:Ope
nedclinical: pls
confirm hx of
cold sores
predates
enrollment and I
will request DM
unlock MedHx
CRF so you can
add this. Thanks
Feb-02-2021
10:39:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Feb-01-2021
09:51:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened clinical: this
information is
missing from
MedHx CRF. Pls
update if hx of
cold sores
predates
enrollment.
Consider
updating AE
term to
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930772
Page 205 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
worsening cold
sores as
appropriate.
Thanks
Jan-29-2021
12:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this even
t is due to:
OTHER
If Other, specify:
Frequently experi
ences cold soresInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-02-2021
13:27:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription
Error
Jan-29-2021 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930773
Page 206 of 241
***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
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
12:09:12
(UTC-05:00)
Eastern Time (US &
Canada)NO
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-29-2021
12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930774
Page 207 of 241
***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, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021 12:41:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-29-2021 12:41:59
(UTC-05:00) Eastern
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
Feb-05-2021
16:55:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
worsening ingrown hairChanged per
query.
Jan-29-2021
12:41:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ingrown hairInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930775
Page 208 of 241
***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, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-29-2021
12:41:02
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021 UNK:UNKTranscription
Error
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-29-2021
12:41:28
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/10/2021 UNK:UN
KTranscription
Error
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/10/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930776
Page 209 of 241
***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, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
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
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-08-2021
13:29:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-05-2021
16:54:48
(UTC-05:00)ACV0PFEINFP6000 Query 1: Answered Please unfreeze
medical history
CRF to update
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930777
Page 210 of 241
***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, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Eastern Time (US
& Canada)pre-existing
condition
appropriately.
Feb-02-2021
12:40:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please determine
if INGROWN
HAIR was a
Pre-Existing
Condition that
should have been
entered on the
Medical History
CRF. If Yes,
determine if this
AE Term should
include
WORSENING.
Please update
and/or clarify.
Jan-29-2021
12:11:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
Frequently experi
ences ingrown ha
irInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0930778
Page 211 of 241
***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, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-29-2021
12:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-29-2021
12:11:50ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (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-2021-5683-0930779
Page 212 of 241
***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, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00) Eastern
Time (US & Canada)
090177e196ae3032\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0930780
Page 213 of 241
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center
Subject No: 11221053 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021 12:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-29-2021 12:16:13
(UTC-05:00) Eastern
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
Jan-29-2021
12:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Infected laceration right th
umbInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-29-2021
12:42:51
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/2/2021 UNK:UNKTranscription
Error
Jan-29-2021
12:16:13ACV0PFEINFP6000 Data Entry:
Jan
…[truncated]