125742 S1 M5 CRF c4591001 1145 11451059

Document text

Page 1 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807755
Page 2 of 254
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807756
Page 3 of 254
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11451059]
2.Birth Date: /2000
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807757
Page 4 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807758
Page 5 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807759
Page 6 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807760
Page 7 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[chronic ear infections]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[heart murmur]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2012
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[gallbladder disease]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[generalized joint hyper-mobility syndrome]
Start Date: UNK/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[depression]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807761
Page 8 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[fribromyalgia]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807762
Page 9 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [139.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [20.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807763
Page 10 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807764
Page 11 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [72415]
3.Randomization Group: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807765
Page 12 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[3.2ml collected for both retain aliquots]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1KC9]
5.bSample ID [BP1KCB]
5.cSample ID [BP1KCC]
5.dSample ID [BPJ199]
5.eSample ID [BPJ19B]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807766
Page 13 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BP1KBX]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807767
Page 14 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 14:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807768
Page 15 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807769
Page 16 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807770
Page 17 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807771
Page 18 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807772
Page 19 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BP1L7R]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807773
Page 20 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 11:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807774
Page 21 of 254
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807775
Page 22 of 254
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BP1LDB]
5.bSample ID [BNW4WD]
5.cSample ID [BNW4WC]
5.dSample ID [BNW4WB]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807776
Page 23 of 254
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807777
Page 24 of 254
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807778
Page 25 of 254
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807779
Page 26 of 254
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807780
Page 27 of 254
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807781
Page 28 of 254
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807782
Page 29 of 254
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807783
Page 30 of 254
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807784
Page 31 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807785
Page 32 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807786
Page 33 of 254
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807787
Page 34 of 254
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807788
Page 35 of 254
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807789
Page 36 of 254
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807790
Page 37 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVEN
T 1  Headache  Aug/28/2020 14:35  NO
End Date Time:
Aug/28/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVEN
T 2  Photophobia  Aug/28/2020 14:35  NO
End Date Time:
Aug/28/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EVEN
T 3  Injection site pai
n Aug/28/2020 14:35  NO
End Date Time:
Aug/31/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EVEN
T 4  Knee pain  Sep/8/2020 UNK:UN
K NO
End Date Time:
Sep/11/2020 UNK:UNK
 Repeating
Pages
 5.ADVERSE EVEN
T 5  Knee swelling  Sep/11/2020 UNK:U
NK NO
End Date Time:
Sep/11/2020 UNK:UNK
 Repeating
Pages
 6.ADVERSE EVEN
T 6  appendicitis  Jan/4/2021 UNK:UN
K NO
End Date Time:
Jan/7/2021 UNK:UNK
 Repeating
Pages
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807791
Page 38 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Headache]
4.Start Date Time: Aug/28/2020 14:35
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 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
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
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807792
Page 39 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807793
Page 40 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Photophobia]
4.Start Date Time: Aug/28/2020 14:35
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 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
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
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807794
Page 41 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807795
Page 42 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Injection site pain]
4.Start Date Time: Aug/28/2020 14:35 Comments
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 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
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
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807796
Page 43 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807797
Page 44 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Knee pain]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 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
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:
[twisted knee]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807798
Page 45 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807799
Page 46 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Knee swelling]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 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
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:
[twisted knee]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807800
Page 47 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807801
Page 48 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[appendicitis]
4.Start Date Time: Jan/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/7/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[the event is related to the appendicitis]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807802
Page 49 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021008409]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807803
Page 50 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryMedication Er
rorStart DateIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.Not Applica
ble Not Applicable  Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807804
Page 51 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of Medication
Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication given? Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807805
Page 52 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807806
Page 53 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807807
Page 54 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807808
Page 55 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807809
Page 56 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Start Date Form Instance
 1.Not Applicabl
e Not Applicable  Not Applicable  Not Applicabl
e Not Applicabl
e Repeating Pages
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807810
Page 57 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807811
Page 58 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807812
Page 59 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807813
Page 60 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807814
Page 61 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807815
Page 62 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807816
Page 63 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807817
Page 64 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807818
Page 65 of 254
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807819
Page 66 of 254
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807820
Page 67 of 254
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807821
Page 68 of 254
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807822
Page 69 of 254
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807823
Page 70 of 254
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807824
Page 71 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807825
Page 72 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/21/2021
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807826
Page 73 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807827
Page 74 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/21/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807828
Page 75 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/21/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807829
Page 76 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9C2M]
5.bSample ID [BNVL1T]
5.cSample ID [BNVL1V]
5.dSample ID [BNVL1W]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807830
Page 77 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9C2C]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807831
Page 78 of 254
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/21/2021 12:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807832
Page 79 of 254
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807833
Page 80 of 254
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/11/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807834
Page 81 of 254
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9C45]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807835
Page 82 of 254
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/11/2021 13:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807836
Page 83 of 254
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807837
Page 84 of 254
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807838
Page 85 of 254
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807839
Page 86 of 254
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807840
Page 87 of 254
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807841
Page 88 of 254
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807842
Page 89 of 254
***Confidential***
 
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Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
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/Death :Mar/11/2021 Comments
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3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807843
Page 90 of 254
***Confidential***
 
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Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
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090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807844
Page 91 of 254
***Confidential***
 
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Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
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090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807845
Page 92 of 254
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
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CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807846
Page 93 of 254
***Confidential***
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Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-28-2020 17:09:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0807847
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***Confidential***
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-22-2020 15:01:21 (UTC-05:00) Eastern Time
(US & Canada)time unknown
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807848
Page 95 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807849
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***Confidential***
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807850
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***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807851
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***Confidential***
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807852
Page 99 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807853
Page 100 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807854
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***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807855
Page 102 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807856
Page 103 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807857
Page 104 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807858
Page 105 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Sep-23-2020 10:21:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807859
Page 106 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-23-2020 10:21:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807860
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***Confidential***
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-23-2020 10:21:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807861
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***Confidential***
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-23-2020 10:21:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807862
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-23-2020 10:21:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807863
Page 110 of 254
***Confidential***
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-23-2020 10:21:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807864
Page 111 of 254
***Confidential***
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-23-2020 10:21:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807865
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807866
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807867
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807868
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807869
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807870
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***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807871
Page 118 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807872
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***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807873
Page 120 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807874
Page 121 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807875
Page 122 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Sep-23-2020 10:22:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807876
Page 123 of 254
***Confidential***
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Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-23-2020 10:22:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807877
Page 124 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-23-2020 10:22:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807878
Page 125 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-23-2020 10:22:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807879
Page 126 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-23-2020 10:22:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807880
Page 127 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-23-2020 10:22:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807881
Page 128 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-23-2020 10:22:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807882
Page 129 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-23-2020 10:22:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807883
Page 130 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-23-2020 10:23:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807884
Page 131 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-23-2020 10:23:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807885
Page 132 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-23-2020 10:23:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807886
Page 133 of 254
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 14:53:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807887
Page 134 of 254
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-21-2021 14:53:42 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807888
Page 135 of 254
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 14:53:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807889
Page 136 of 254
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-21-2021 14:53:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807890
Page 137 of 254
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 14:54:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807891
Page 138 of 254
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormMar-11-2021 13:33:26 (UTC-05:00) Eastern Time
(US & Canada)
FormMar-01-2021 12:18:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormFeb-11-2021 14:41:47 (UTC-05:00) Eastern Time
(US & Canada)
FormJan-25-2021 10:29:09 (UTC-05:00) Eastern Time
(US & Canada)updated per query as NA
Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807892
Page 139 of 254
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Mar-11-2021 13:33:26 (UTC-05:00) Eastern Time
(US & Canada)
1Mar-01-2021 12:18:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
1Feb-11-2021 14:41:47 (UTC-05:00) Eastern Time
(US & Canada)
1Jan-25-2021 10:29:09 (UTC-05:00) Eastern Time
(US & Canada)updated per query as NA
Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807893
Page 140 of 254
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Mar-11-2021 13:33:26 (UTC-05:00) Eastern Time
(US & Canada)
2Mar-01-2021 12:18:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Feb-11-2021 14:41:47 (UTC-05:00) Eastern Time
(US & Canada)
2Jan-25-2021 10:29:09 (UTC-05:00) Eastern Time
(US & Canada)updated per query as NA
Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807894
Page 141 of 254
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Mar-11-2021 13:33:26 (UTC-05:00) Eastern Time
(US & Canada)
3Mar-01-2021 12:18:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
3Feb-11-2021 14:41:47 (UTC-05:00) Eastern Time
(US & Canada)
3Jan-25-2021 10:29:09 (UTC-05:00) Eastern Time
(US & Canada)updated per query as NA
Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807895
Page 142 of 254
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Mar-11-2021 13:33:26 (UTC-05:00) Eastern Time
(US & Canada)
4Mar-01-2021 12:18:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Feb-11-2021 14:41:47 (UTC-05:00) Eastern Time
(US & Canada)
4Jan-25-2021 10:29:09 (UTC-05:00) Eastern Time
(US & Canada)updated per query as NA
Not Applicable
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807896
Page 143 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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-22-2021 10:46:31 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 16:37:28 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-21-2021 16:35:55 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 16:29:18 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-20-2021 09:57:31 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807897
Page 144 of 254
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
N/A
 Approved Jan-15-2021 08:55:50 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-06-2021 16:47:19 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kawsar Talaat  Approved Nov-09-2020 13:04:34 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KawsarTalaat, 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.
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807898
Page 145 of 254
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 17:08:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 17:08:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807899
Page 146 of 254
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 17:08:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807900
Page 147 of 254
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 17:08:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11451059Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 17:08:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/2000Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 17:08:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 17:08:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 17:08:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807901
Page 148 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 17:09:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807902
Page 149 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 17:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 17:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 17:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807903
Page 150 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 17:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:chronic ear infect
ions
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 17:12:27
(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
Aug-28-2020 17:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
chronic ear infectionsInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 17:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 17:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020 17:13:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807904
Page 151 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Medical History Te
rm:heart murmur
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2
012
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 17:13:19
(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 Value Reason
Aug-28-2020 17:13:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
heart murmurInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 17:13:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 17:13:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.c
Date Location User Value Reason
Aug-28-2020 17:14:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:gallbladder disea
seInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807905
Page 152 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2
019
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 17:14:13
(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
Aug-28-2020 17:14:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
gallbladder diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 17:14:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 17:14:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.d
Date Location User Value Reason
Aug-28-2020 17:15:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:generalized joint hyper-
mobility syndrome
Start Date: UNK/UNK/2019Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807906
Page 153 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 17:15:34
(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
Aug-28-2020 17:15:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
generalized joint hyper-mobility synd
romeInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 17:15:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 17:15:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-28-2020 17:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:depression
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807907
Page 154 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 17:17:17
(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
Aug-28-2020 17:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 17:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 17:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-28-2020 17:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:fribromyalgia
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807908
Page 155 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020 17:17:57
(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
Aug-28-2020 17:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
fribromyalgiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020 17:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020 17:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807909
Page 156 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
139.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.5Initial Entry
7.a
Date Location User Value Reason
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0807910
Page 157 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 17:22:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 99.1
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DTranscription Error
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 99.7
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 17:22:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 17:22:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
99.1Transcription Error
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 99.7 F is
outside of Normal
Range 97 - 99.5 F.
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
99.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807911
Page 158 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-28-2020 17:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807912
Page 159 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807913
Page 160 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807914
Page 161 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 17:22:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 17:22:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
72415Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807915
Page 162 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 17:46:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 17:46:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 17:46:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 17:46:06
(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.
Aug-28-2020 17:46:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-28-2020 17:47:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3.2ml collected for both retain aliquot
sInitial Entry
5.a
Date Location User Value Reason
Aug-28-2020 17:46:21
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807916
Page 163 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) Sample ID: BP1KC9
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 17:46:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1KC9Initial Entry
5.b
Date Location User Value Reason
Aug-28-2020 17:46:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1KCBInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 17:46:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1KCBInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 17:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1KCCInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 17:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1KCCInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 17:46:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ199Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807917
Page 164 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 17:46:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPJ199Initial Entry
5.e
Date Location User Value Reason
Aug-28-2020 17:47:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ19BInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 17:47:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPJ19BInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807918
Page 165 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 17:48:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 17:48:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 17:48:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 17:48:11
(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.
Aug-28-2020 17:48:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 17:48:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1KBXInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 17:48:22
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP1KBXInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807919
Page 166 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0807920
Page 167 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 14:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807921
Page 168 of 254
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 17:23:08
(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
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-28-2020 17:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807922
Page 169 of 254
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 17:23:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807923
Page 170 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 12:41:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807924
Page 171 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 12:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 12:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 99.1
Temperature Unit: F
Temperature Location:
:FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 12:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 12:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
99.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 12:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 12:41:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807925
Page 172 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807926
Page 173 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 12:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807927
Page 174 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 13:25:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 13:25:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 13:25:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 13:25:34
(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.
Sep-18-2020 13:25:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 13:25:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1L7RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 13:25:47
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP1L7RInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807928
Page 175 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0807929
Page 176 of 254
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 11:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807930
Page 177 of 254
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-18-2020 12:43:20
(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
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-18-2020 12:43:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807931
Page 178 of 254
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-06-2020
17:46:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-06-2020
11:37:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredvisit is out of the window due
to scheduling issues.
Nov-06-2020
04:48:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 13 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Nov-05-2020
11:57:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Nov/5
/2020Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807932
Page 179 of 254
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 11:58:21
(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 11:58:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 13:08:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 11:58:21
(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.
Nov-05-2020 11:58:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020 13:08:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1LDBInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 13:08:52
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP1LDBInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807933
Page 180 of 254
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
5.b
Date Location User Value Reason
Nov-05-2020 13:09:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4WDInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-05-2020 13:09:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4WDInitial Entry
5.c
Date Location User Value Reason
Nov-05-2020 13:09:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4WCInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-05-2020 13:09:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4WCInitial Entry
5.d
Date Location User Value Reason
Nov-05-2020 13:09:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4WBInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-05-2020 13:09:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4WBInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807934
Page 181 of 254
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-05-2020 11:58:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020 11:58:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-05-2020 11:58:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807935
Page 182 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807936
Page 183 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807937
Page 184 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807938
Page 185 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807939
Page 186 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807940
Page 187 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807941
Page 188 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 14:57:55
(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
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 14:35Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/28/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807942
Page 189 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 14:57:55
(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
Sep-22-2020 14:57:55
(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
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807943
Page 190 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 14:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807944
Page 191 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 15:00:22
(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
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PhotophobiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 14:35Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/28/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807945
Page 192 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 15:00:22
(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
Sep-22-2020 15:00:22
(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
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807946
Page 193 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 15:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807947
Page 194 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 15:01:02
(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
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020 09:08:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Data updated.
Sep-29-2020 12:23:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Sep-29-2020 12:23:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 14:35Called participant to
answer query
Sep-23-2020 15:00:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Thank you for
response. As you
mentioned the start
date is after a
vaccination
date.Please consider
to provide the start
date time.
Sep-23-2020 10:21:21 ACV0PFEINFP6000  Query 1: Answered AE started after
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0807948
Page 195 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern Time
(US & Canada)vaccination
Sep-23-2020 01:15:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Thanks for the
response. As Start
Date is the same as a
Vaccination Date,
please consider to
provide the best
estimated time else
confirm if adverse
event started before
or after the
vaccination.
Sep-22-2020 15:02:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Time unknown
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Injection site
pain : Start Date is
the same as a
Vaccination Date, but
time is not provided.
Please review and
update as appropriate.
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/31/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807949
Page 196 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 15:01:02
(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
Sep-22-2020 15:01:02
(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
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807950
Page 197 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 15:01:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807951
Page 198 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 15:03:14
(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
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Knee painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/11/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807952
Page 199 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 15:03:14
(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
Sep-22-2020 15:03:14
(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
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
twisted kneeInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0807953
Page 200 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 15:03:14
(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
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 15:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807954
Page 201 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 15:03:55
(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
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Knee swellingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/11/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807955
Page 202 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 15:03:55
(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
Sep-22-2020 15:03:55
(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
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
twisted kneeInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0807956
Page 203 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 15:03:55
(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
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 15:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807957
Page 204 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-06-2021 16:47:19
(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-06-2021 16:47:19
(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
Jan-15-2021 09:38:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-14-2021 18:34:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Thank you for the
response. Updates to
the safety report have
been noted. Is the
pathology report
available? Thanks.
Jan-11-2021 09:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered all lab results, and
covid testing report etc
will be provided as it
becomes available
Jan-10-2021 12:01:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened CLINIQUERY_
Kindly provide, if
available, results from
relevant lab test,
including covid testing
and pathology report in
a FU SAE form to be
added in the narrative.
Thank you
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
appendicitisInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807958
Page 205 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4. Start Date Time:
Date Location User Value Reason
Jan-14-2021 23:39:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-13-2021 13:44:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered The onset date for the
SAE of appendicitis is
04Jan2021. Per
medical records, the
initial GI symptoms
were related to
gastroparesis. An
updated SAE report
will be submitted to
change the POTS
syndrome diagnosis to
21Dec2020.
Jan-13-2021 13:44:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021 UNK:UNKThe onset date for the
SAE of appendicitis is
04Jan2021. Per
medical records, the
initial GI symptoms
were related to
gastroparesis. An
updated SAE report
will be submitted to
change the POTS
syndrome diagnosis to
21Dec2020.
Jan-12-2021 21:36:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON: The
onset date recorded in
the CRF was
03Dec2020. Per
previous query
response 'The onset
date is Jan4th 2021'.
Please update
accordingly
Jan-08-2021 09:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered The onset date is
Jan4th 2021, a follow
up SAE form will be
submitted as the
confusion in the onset
dates are cleared.
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807959
Page 206 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-08-2021 04:30:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021008409
,onset date was
recorded as 04Jan2021
in Safety database
however, recorded as
03Dec2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please submit
a follow-up SAE form.
Jan-07-2021 09:08:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/3/2020 UNK:UNKTranscription Error
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-21-2021 09:13:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/7/2021 UNK:UNKNew Information
Jan-06-2021 16:48:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/6/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807960
Page 207 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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-22-2021 10:39:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 3: Closed Response satisfies
query
Jan-21-2021 12:04:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Jan-21-2021 12:04:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening?
NO
Other medically important serious e
vent
NOTranscription Error
Jan-21-2021 11:10:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 3: Reissued:Opened GPDClin: Thank you
for the change. Please
also clarify if "Yes" for
life threatening
criterion, which means
the subject had
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807961
Page 208 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
immediate risk of
death during the event.
If no, please change it
accordingly.
Jan-20-2021 09:58:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Jan-20-2021 09:58:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening?
YES
Other medically important serious e
vent
NOTranscription Error
Jan-19-2021 22:51:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 3: Opened GPDClin: Per SAE
report, this SAE
criterion was
hospitalization. Please
make the change
accordingly.
Jan-08-2021 04:26:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807962
Page 209 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-06-2021 16:48:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-06-2021 16:48:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or pro
long hospitalization?
NO
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening?
YES
Other medically important serious e
vent
NOTranscription Error
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE appendicitis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Is the adverse event
serious?' is marked as
YES, but responses to
all of the seriousness
criteria are NO. At
least one seriousness
criterion is expected to
be YES for serious
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807963
Page 210 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
events. Please review
and update as
appropriate.
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or pro
long hospitalization?
NO
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening?
NO
Other medically important serious e
vent
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-06-2021 16:47:19
(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
Jan-12-2021 16:54:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s),Transcription Error
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807964
Page 211 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
this event is due to:
OTHER
If Other, specify:
the event is related to the appen
dicitis
Jan-06-2021 16:47:19
(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:
appendicitisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-06-2021 16:47:19
(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-11-2021 20:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-11-2021 09:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-11-2021 09:01:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Jan-11-2021 08:47:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if any
medication was given
for this SAE?
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807965
Page 212 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 20:06:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-11-2021 08:59:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-11-2021 08:59:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Jan-11-2021 08:46:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Per SAE
report, appendectomy
was performed. If
that's correct, please
change this to "Yes".
Jan-06-2021 16:47:19
(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-21-2021
15:37:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 3: C
losedAuto closed by
Validation Check:
VC_AE001_35
Jan-21-2021
09:13:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: A
nsweredend date is updated thank
u
Jan-21-2021
04:54:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: C
losedResponse satisfies query
Jan-20-2021
15:21:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 3: O
penedDMW6907127;Response
to "What was the
outcome of this adverse
event?" is
'Recovered/Resolved' or
'Recovered/Resolved
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807966
Page 213 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
with Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807967
Page 214 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-20-2021 09:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Jan-20-2021 09:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DNew Information
Jan-20-2021 05:01:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2021008409,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Jan-06-2021 16:48:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-06-2021 16:47:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE appendicitis: Response to
"What was the outcome of this
adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Jan-06-2021 16:47:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-06-2021 16:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-08-2021 04:26:28
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
2021008409Initial Entry
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (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-2021-5683-0807968
Page 215 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0807969
Page 216 of 254
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 10:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Sep-23-2020 10:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Sep-23-2020 10:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Sep-23-2020 10:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 10:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 10:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2fe6\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807970
Page 217 of 254
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
S
…[truncated]