125742 S1 M5 CRF c4591001 1145 11451055

Document text

Page 1 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807175
Page 2 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807176
Page 3 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11451055]
2.Birth Date: /1946
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:
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807177
Page 4 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807178
Page 5 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807179
Page 6 of 259
***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: 11451055 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: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807180
Page 7 of 259
***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: 11451055 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:[Exfoliation glaucoma, stable]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Liposuction]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High blood pressure, stable]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism, controlled]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807181
Page 8 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Trabeculectomy]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tear duct surgery]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eyelid surgery]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807182
Page 9 of 259
***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: 11451055 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: [169.0]
3.Unit: LB
4.Height: [62.5]
5.Unit: in
6.Body Mass Index: [30.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807183
Page 10 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807184
Page 11 of 259
***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: 11451055 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: [241070]
3.Randomization Group: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807185
Page 12 of 259
***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: 11451055 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:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1KBC]
5.bSample ID [BP1KBD]
5.cSample ID [BP1KBF]
5.dSample ID [BPJ18Z]
5.eSample ID [BPJ190]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807186
Page 13 of 259
***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: 11451055 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 [BP1KB9]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807187
Page 14 of 259
***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: 11451055 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 11:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807188
Page 15 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807189
Page 16 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807190
Page 17 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807191
Page 18 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807192
Page 19 of 259
***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: 11451055 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/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1L75]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807193
Page 20 of 259
***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: 11451055 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/17/2020 13:07
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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807194
Page 21 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807195
Page 22 of 259
***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: 11451055 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:
Oct/20/2020
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 [BP1LBS]
5.bSample ID [BNW4NP]
5.cSample ID [BNW4NR]
5.dSample ID [BNW4NS]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807196
Page 23 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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:
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807197
Page 24 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807198
Page 25 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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 [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807199
Page 26 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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 [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807200
Page 27 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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?
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807201
Page 28 of 259
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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:
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807202
Page 29 of 259
***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: 11451055 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:
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807203
Page 30 of 259
***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: 11451055 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 [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807204
Page 31 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807205
Page 32 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807206
Page 33 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807207
Page 34 of 259
***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: 11451055 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: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807208
Page 35 of 259
***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: 11451055 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:
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807209
Page 36 of 259
***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: 11451055 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 [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807210
Page 37 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identif
ierAdverse Eve
ntStart DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  atrial fibrillati
on Dec/12/2020 UNK:
UNK NO
End Date Time:
Dec/13/2020 UNK:UNK
 Repeating
Pages
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807211
Page 38 of 259
***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: 11451055 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)[atrial fibrillation] Comments
4.Start Date Time: Dec/12/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/13/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807212
Page 39 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
[idiopathic, patient was advised to follow up with the
cardiologist]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020516872]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807213
Page 40 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.Not Applic
able Not Applicabl
e Not Applic
able Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807214
Page 41 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807215
Page 42 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807216
Page 43 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807217
Page 44 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Applica
ble Repeating
Pages
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807218
Page 45 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807219
Page 46 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Start Date Form Instance
 1.Not Applica
ble Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807220
Page 47 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807221
Page 48 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807222
Page 49 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807223
Page 50 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807224
Page 51 of 259
***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: 11451055 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:
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807225
Page 52 of 259
***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: 11451055 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:
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807226
Page 53 of 259
***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: 11451055 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?
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807227
Page 54 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807228
Page 55 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807229
Page 56 of 259
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807230
Page 57 of 259
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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 local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807231
Page 58 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807232
Page 59 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807233
Page 60 of 259
***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: 11451055 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
[ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807234
Page 61 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807235
Page 62 of 259
***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: 11451055 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/19/2021
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807236
Page 63 of 259
***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: 11451055 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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807237
Page 64 of 259
***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: 11451055 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/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807238
Page 65 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807239
Page 66 of 259
***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: 11451055 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/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNW4RX]
5.bSample ID [BNW4RY]
5.cSample ID [BNW4RZ]
5.dSample ID [BM9C1R]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807240
Page 67 of 259
***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: 11451055 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/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9C1J]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807241
Page 68 of 259
***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: 11451055 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/19/2021 13:06
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
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807242
Page 69 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807243
Page 70 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807244
Page 71 of 259
***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: 11451055 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/9/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9C3V]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807245
Page 72 of 259
***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: 11451055 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/9/2021 12:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807246
Page 73 of 259
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807247
Page 74 of 259
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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/9/2021
3.Comments: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807248
Page 75 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807249
Page 76 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807250
Page 77 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807251
Page 78 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807252
Page 79 of 259
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/9/2021 Comments
2.Phase of Disposition: OPEN LABEL TREATMENT Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807253
Page 80 of 259
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807254
Page 81 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807255
Page 82 of 259
***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: 11451055 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:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807256
Page 83 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-28-2020 13:05:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807257
Page 84 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807258
Page 85 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Aug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807259
Page 86 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Aug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807260
Page 87 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Aug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807261
Page 88 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Aug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807262
Page 89 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Aug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807263
Page 90 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aAug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807264
Page 91 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aAug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807265
Page 92 of 259
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aAug-28-2020 13:23:24 (UTC-05:00) Eastern
Time (US & Canada)postmenopausal for 20+ years
Not Done
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807266
Page 93 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807267
Page 94 of 259
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-17-2020 13:41:17 (UTC-05:00) Eastern
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090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aSep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aSep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
6.aSep-17-2020 13:41:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Jan-15-2021 16:46:50 (UTC-05:00) Eastern
Time (US & Canada)The volunteer has not yet scheduled the
procedure, we will update as soon as we have an
update.
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
FormDec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
1Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
10Dec-23-2020 14:01:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
FormDec-23-2020 14:02:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
1Dec-23-2020 14:02:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Dec-23-2020 14:02:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
3Dec-23-2020 14:02:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
4Dec-23-2020 14:02:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5Dec-23-2020 14:02:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
FormDec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) 
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
1Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) 
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
6Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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7Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
8Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
9Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) 
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
10Dec-23-2020 14:02:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormDec-23-2020 14:02:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
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(b) (4)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Dec-23-2020 14:02:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Dec-23-2020 14:02:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Dec-23-2020 14:02:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Dec-23-2020 14:02:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Dec-23-2020 14:02:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807310
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***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Dec-23-2020 14:02:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807311
Page 138 of 259
***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormDec-23-2020 14:02:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807312
Page 139 of 259
***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Dec-23-2020 14:02:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807313
Page 140 of 259
***Confidential***
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Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Dec-23-2020 14:02:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807314
Page 141 of 259
***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-19-2021 16:07:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807315
Page 142 of 259
***Confidential***
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Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-19-2021 16:07:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807316
Page 143 of 259
***Confidential***
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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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-19-2021 16:07:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807317
Page 144 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-19-2021 16:07:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807318
Page 145 of 259
***Confidential***
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Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
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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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-19-2021 16:08:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807319
Page 146 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807320
Page 147 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807321
Page 148 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Jan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807322
Page 149 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Jan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807323
Page 150 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Jan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807324
Page 151 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Jan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807325
Page 152 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aJan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807326
Page 153 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aJan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807327
Page 154 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aJan-19-2021 16:09:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807328
Page 155 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-0807329
Page 156 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Feb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-0807330
Page 157 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Feb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807331
Page 158 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Feb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807332
Page 159 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Feb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807333
Page 160 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Feb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807334
Page 161 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aFeb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807335
Page 162 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aFeb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807336
Page 163 of 259
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aFeb-09-2021 14:02:29 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807337
Page 164 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormMar-09-2021 11:01:44 (UTC-05:00) Eastern
Time (US & Canada)
FormMar-01-2021 12:15:23 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807338
Page 165 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Mar-09-2021 11:01:44 (UTC-05:00) Eastern
Time (US & Canada)
1Mar-01-2021 12:15:23 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807339
Page 166 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Mar-09-2021 11:01:44 (UTC-05:00) Eastern
Time (US & Canada)
2Mar-01-2021 12:15:23 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807340
Page 167 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Mar-09-2021 11:01:44 (UTC-05:00) Eastern
Time (US & Canada)
3Mar-01-2021 12:15:23 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807341
Page 168 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Mar-09-2021 11:01:44 (UTC-05:00) Eastern
Time (US & Canada)
4Mar-01-2021 12:15:23 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807342
Page 169 of 259
***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: 11451055 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 15:16:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 16:28:57 (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-15-2021 16:46:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-15-2021 08:54:50 (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.
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807343
Page 170 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
 N/A Dec-23-2020 14:01:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kawsar Talaat  Approved Oct-27-2020 13:49:48 (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.
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807344
Page 171 of 259
***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: 11451055 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 13:04:21
(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 13:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807345
Page 172 of 259
***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: 11451055 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 13:04:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Aug/28/2020Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807346
Page 173 of 259
***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: 11451055 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 13:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11451055Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 13:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 13:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 13:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fe2\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-2021-5683-0807347
Page 174 of 259
***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: 11451055 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 13:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807348
Page 175 of 259
***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: 11451055 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 13:05:43
(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 13:05:43
(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 13:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807349
Page 176 of 259
***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: 11451055 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 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:Exfoliation glauc
oma, stable
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:09:06
(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 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exfoliation glaucoma, stableInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 13:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe2\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-2021-5683-0807350
Page 177 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b
Date Location User Value Reason
Aug-28-2020 13:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Liposuction
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/
2000Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807351
Page 178 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:09:47
(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 13:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LiposuctionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 13:09:47
(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 13:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.c
Date Location User Value Reason
Aug-28-2020 13:10:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:High blood press
ure, stable
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae2fe2\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-2021-5683-0807352
Page 179 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:10:57
(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 13:10:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
High blood pressure, stableInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 13:10:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 13:10:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-28-2020 13:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:Hypothyroidism,
controlled
Start Date: UNK/UNK/1998
Ongoing: YESInitial Entry
090177e196ae2fe2\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-2021-5683-0807353
Page 180 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:12:53
(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 13:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hypothyroidism, controlledInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 13:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 13:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-28-2020 13:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Trabeculectom
y
Start Date: UNK/UNK/201
8Initial Entry
090177e196ae2fe2\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-2021-5683-0807354
Page 181 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: NO
End Date:
UNK/UNK/
2018
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:20:48
(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 13:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TrabeculectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 13:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 13:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.f
Date Location User Value Reason
Aug-28-2020 13:21:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6Initial Entry
090177e196ae2fe2\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-2021-5683-0807355
Page 182 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Medical History
Term:Tear duct surge
ry
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/
2000
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:21:16
(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 13:21:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Tear duct surgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020 13:21:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020 13:21:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.g
Date Location User Value Reason
090177e196ae2fe2\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-2021-5683-0807356
Page 183 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 13:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:Eyelid surgery
Start Date: UNK/UNK/198
0
Ongoing: NO
End Date:
UNK/UNK/
1980Initial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020 13:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 13:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Eyelid surgeryInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-28-2020 13:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020 13:35:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1980Initial Entry
090177e196ae2fe2\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-2021-5683-0807357
Page 184 of 259
***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: 11451055 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 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
169.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
62.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.4Initial Entry
090177e196ae2fe2\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-2021-5683-0807358
Page 185 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.7
Temperature Unit
:F
Temperature Loc
ation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 13:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fe2\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-2021-5683-0807359
Page 186 of 259
***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: 11451055 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 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fe2\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-2021-5683-0807360
Page 187 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide
ntifier:Not Do
ne
Test:: Not Do
ne
Result:: Not Do
ne
Not Done:: Not Do
neInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-28-2020 13:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fe2\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-2021-5683-0807361
Page 188 of 259
***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: 11451055 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 17:24:38
(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 17:24:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
241070Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807362
Page 189 of 259
***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: 11451055 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 17:33:51
(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 17:33:51
(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 17:34:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 17:33:51
(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 17:33:51
(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 17:34:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1KBCInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807363
Page 190 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 17:34:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1KBCInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 17:34:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1KBDInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 17:34:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1KBDInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 17:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1KBFInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 17:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1KBFInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 17:35:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ18ZInitial Entry
090177e196ae2fe2\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-2021-5683-0807364
Page 191 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 17:35:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPJ18ZInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020 17:35:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ190Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 17:35:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPJ190Initial Entry
090177e196ae2fe2\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-2021-5683-0807365
Page 192 of 259
***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: 11451055 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 17:35:58
(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 17:35:58
(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 17:35:58
(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 17:35:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1KB9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 17:35:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1KB9Initial Entry
090177e196ae2fe2\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-2021-5683-0807366
Page 193 of 259
***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: 11451055 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 13:24:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 13:24:12
(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 13:24:12
(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 13:24:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 11:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 13:24:12
(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 13:24:12
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2fe2\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-2021-5683-0807367
Page 194 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-28-2020 13:24:12
(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 13:24:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 13:24:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807368
Page 195 of 259
***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: 11451055 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 13:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807369
Page 196 of 259
***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: 11451055 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-17-2020 13:40:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807370
Page 197 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 13:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 13:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 13:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 13:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 13:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae2fe2\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-2021-5683-0807371
Page 198 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-17-2020 13:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807372
Page 199 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fe2\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-2021-5683-0807373
Page 200 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-17-2020 13:41:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807374
Page 201 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 15:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 15:04:55
(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-17-2020 15:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 15:04:55
(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-17-2020 15:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 15:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1L75Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807375
Page 202 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 15:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1L75Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807376
Page 203 of 259
***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: 11451055 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-17-2020 13:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 13:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 13:41:46
(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-17-2020 13:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020 13:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 13:41:46
(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-17-2020 13:41:46
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2fe2\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-2021-5683-0807377
Page 204 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-17-2020 13:41:46
(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-17-2020 13:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-17-2020 13:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807378
Page 205 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 12:11:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807379
Page 206 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 13:35:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 13:35:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 13:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 13:35:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-20-2020 13:35:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1LBSInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807380
Page 207 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 13:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1LBSInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4NPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 13:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4NPInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4NRInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 13:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4NRInitial Entry
5.d
Date Location User Value Reason
Oct-20-2020 13:37:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4NSInitial Entry
090177e196ae2fe2\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-2021-5683-0807381
Page 208 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Oct-20-2020 13:37:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4NSInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807382
Page 209 of 259
***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: 11451055 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
Oct-20-2020 12:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 12:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 12:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807383
Page 210 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807384
Page 211 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-23-2020 14:01:38
(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
Jan-22-2021 16:09:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed ok. thanks
Jan-15-2021 16:33:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered we definitely will do
that.Thank u
Jan-15-2021 10:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Thanks for
confirming. Please
make every effort
possible to obtain
further information
and respond to the
query once
additional
information is
available.
Jan-15-2021 09:23:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered volunteer is going to
have the procedure,
we will update as
soon as we have the
update , thank u
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807385
Page 212 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-15-2021 08:55:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Thanks for your
response. Would
you kindly clarify
what was the
procedure
performed? Thank
you.
Jan-11-2021 13:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered not associated to
investigational
product
Jan-08-2021 17:12:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_ Per SAE
report, the subject
had a "glaucoma
procedure". Kindly
clarify what was the
procedure and if this
was a programed
intervention in a FU
form. Thank you
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
atrial fibrillationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/12/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/13/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fe2\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-2021-5683-0807386
Page 213 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-14-2021 11:07:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-07-2021 15:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-07-2021 15:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Transcription Error
Jan-07-2021 12:29:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Per AE log, AE is
rated 3. Please
review and clarify
or confirm as
appropriate.
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-02-2021 01:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE atrial
fibrillation:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associatedInitial Entry
090177e196ae2fe2\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-2021-5683-0807387
Page 214 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-30-2020 13:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0807388
Page 215 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-29-2020 10:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-29-2020 10:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
idiopathic, patient was adv
ised to follow up with the
cardiologistTranscription Error
Dec-28-2020 17:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
confirm if the study
vaccine given 3
months ago was
considered the
likely cause of the
SAE. If yes, please
elaborate the
rationale. If no,
please make the
corresponding
change here.
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-23-2020 14:01:38
(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-04-2021 14:16:54
(UTC-05:00) EasternACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
090177e196ae2fe2\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)
FDA-CBER-2021-5683-0807389
Page 216 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Jan-04-2021 10:19:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-04-2021 10:19:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Jan-03-2021 16:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Per SAE
report, medications
were given to treat
this AE. If that's
correct, please
change this to
"Yes".
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-23-2020 14:01:38
(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
Dec-23-2020 14:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae2fe2\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) (4)
(b) (4)
FDA-CBER-2021-5683-0807390
Page 217 of 259
***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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Jan-02-2021 01:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020516872Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807391
Page 218 of 259
***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, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020 14:01:53
(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
Dec-23-2020 14:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Dec-23-2020 14:01:53
(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
Dec-23-2020 14:01:53
(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
Dec-23-2020 14:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-23-2020 14:01:53
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807392
Page 219 of 259
***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, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-23-2020 14:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-23-2020 14:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Dec-23-2020 14:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-23-2020 14:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807393
Page 220 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Dec-23-2020 14:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Dec-23-2020 14:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Dec-23-2020 14:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown,
enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route,
use, formulation).
Date Location User Value Reason
Dec-23-2020 14:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Dec-23-2020 14:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807394
Page 221 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF
Audit Trail History
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown,
enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route,
use, formulation).
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807395
Page 222 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF
Audit Trail History
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
6. Dose Unit:
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Route:
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Start Date:
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Ongoing?
Date Location User Value Reason
Dec-23-2020 14:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807396
Page 223 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020 14:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. What is the treatment Identifier?
Date Location User Value Reason
Dec-23-2020 14:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Dec-23-2020 14:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Dec-23-2020 14:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Dec-23-2020 14:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Dec-23-2020 14:02:38
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807397
Page 224 of 259
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0807398
Page 225 of 259
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - eCRF Audit Trail History
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Transfusion Type:
Date Location User Value Reason
Dec-23-2020 14:02:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Dec-23-2020 14:02:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807399
Page 226 of 259
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021 11:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-22-2021 15:16:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-22-2021 15:16:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Transcription Error
Jan-22-2021 13:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Per CRF completion
guidelines, initial
contact to determine
if subject can receive
study vaccine will be
documented in
REVAX_CONTACT
Visit. Per source, date
of initial contact is
14Jan2021. Please
clarify or confirm as
appropriate.
Jan-19-2021 16:07:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae2fe2\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-2021-5683-0807400
Page 227 of 259
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021 16:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Transcription Error
Jan-19-2021 16:08:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Transcription Error
Jan-19-2021 16:07:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2fe2\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-2021-5683-0807401
Page 228 of 259
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021 16:06:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021 16:06:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807402
Page 229 of 259
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-19-2021 16:07:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807403
Page 230 of 259
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
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: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-19-2021 16:07:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807404
Page 231 of 259
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807405
Page 232 of 259
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021 16:08:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/19/2021Initial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807406
Page 233 of 259
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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
Jan-19-2021 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807407
Page 234 of 259
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fe2\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-2021-5683-0807408
Page 235 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-19-2021 16:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fe2\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-2021-5683-0807409
Page 236 of 259
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 16:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 16:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 17:05:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 16:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-19-2021 16:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021 17:05:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4RXInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807410
Page 237 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Jan-19-2021 17:05:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4RXInitial Entry
5.b
Date Location User Value Reason
Jan-19-2021 17:06:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4RYInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-19-2021 17:06:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4RYInitial Entry
5.c
Date Location User Value Reason
Jan-19-2021 17:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW4RZInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-19-2021 17:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW4RZInitial Entry
5.d
Date Location User Value Reason
Jan-19-2021 17:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9C1RInitial Entry
090177e196ae2fe2\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-2021-5683-0807411
Page 238 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Jan-19-2021 17:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM9C1RInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807412
Page 239 of 259
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 16:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 16:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 17:06:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 16:09:49
(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.
Jan-19-2021 16:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021 17:06:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9C1JInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807413
Page 240 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Jan-19-2021 17:06:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM9C1JInitial Entry
090177e196ae2fe2\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0807414
Page 241 of 259
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 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
Jan-19-2021 16:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021 16:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021 16:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-19-2021 16:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 13:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021 16:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021 16:10:11
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2fe2\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-2021-5683-0807415
Page 242 of 259
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User V
…[truncated]