125742 S1 M5 CRF c4591001 1204 12041078

Document text

Page 1 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988350
Page 2 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988351
Page 3 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12041078]
2.Birth Date: 1976
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988352
Page 4 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988353
Page 5 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988354
Page 6 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988355
Page 7 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Herniated Disc]
Start Date: Oct/1/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Vasectomy]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988356
Page 8 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [170.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [27.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988357
Page 9 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [85740]
3.Randomization Group: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988358
Page 10 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BNWL3W]
5.bSample ID [BNWL3X]
5.cSample ID [BPYM3R]
5.dSample ID [BNWL3M]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988359
Page 11 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BPYM3K]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988360
Page 12 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/9/2020 17:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988361
Page 13 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988362
Page 14 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988363
Page 15 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988364
Page 16 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
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 [BPYN3P]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988365
Page 17 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/30/2020 16:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988366
Page 18 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988367
Page 19 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BRC016]
5.bSample ID [BSMGW7]
5.cSample ID [BSMGW4]
5.dSample ID [BSMGW3]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988368
Page 20 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988369
Page 21 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988370
Page 22 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988371
Page 23 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988372
Page 24 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988373
Page 25 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988374
Page 26 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988375
Page 27 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988376
Page 28 of 162
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988377
Page 29 of 162
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988378
Page 30 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988379
Page 31 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988380
Page 32 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988381
Page 33 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988382
Page 34 of 162
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Ev
ent Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  Swollen lymph nodes
neck area (left side ) Feb/5/20
21 12:00 YES  Repeating
Pages
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988383
Page 35 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Swollen lymph nodes neck area (left side )]
4.Start Date Time: Feb/5/2021 12:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988384
Page 36 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988385
Page 37 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988386
Page 38 of 162
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988387
Page 39 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988388
Page 40 of 162
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988389
Page 41 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988390
Page 42 of 162
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988391
Page 43 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988392
Page 44 of 162
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988393
Page 45 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988394
Page 46 of 162
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988395
Page 47 of 162
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988396
Page 48 of 162
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988397
Page 49 of 162
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988398
Page 50 of 162
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988399
Page 51 of 162
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988400
Page 52 of 162
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988401
Page 53 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988402
Page 54 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988403
Page 55 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988404
Page 56 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/14/2021
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988405
Page 57 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988406
Page 58 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988407
Page 59 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BPVRYJ]
5.bSample ID [BS1GXC]
5.cSample ID [BS1GXB]
5.dSample ID [BS1GWJ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988408
Page 60 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BPVRYK]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988409
Page 61 of 162
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/14/2021 15:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988410
Page 62 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988411
Page 63 of 162
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988412
Page 64 of 162
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988413
Page 65 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988414
Page 66 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [BPVS2Z]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988415
Page 67 of 162
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/4/2021 15:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988416
Page 68 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988417
Page 69 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/5/2021
3.Comments: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988418
Page 70 of 162
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988419
Page 71 of 162
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988420
Page 72 of 162
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988421
Page 73 of 162
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988422
Page 74 of 162
***Confidential***
 
Header Text: C4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/5/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988423
Page 75 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/28/2020
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988424
Page 76 of 162
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988425
Page 77 of 162
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988426
Page 78 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormSep-09-2020 18:39:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988427
Page 79 of 162
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-14-2021 17:15:24
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988428
Page 80 of 162
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 Feb-04-2021 17:08:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Judith
Aberg Approved Jan-25-2021 14:02:06 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JudithAberg, 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.
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988429
Page 81 of 162
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Jan-12-2021 16:50:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-30-2020 10:27:08 (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.
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988430
Page 82 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-09-2020
18:38:18
(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
Sep-09-2020
18:38:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988431
Page 83 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020
18:38:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/9/2020Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988432
Page 84 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020
18:38:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12041078Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020
18:38:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1976Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020
18:38:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988433
Page 85 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-09-2020
18:38:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-09-2020
18:38:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988434
Page 86 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020
18:38:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988435
Page 87 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-09-2020
18:39:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020
18:39:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020
18:39:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988436
Page 88 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Sep-09-2020
18:40:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Herniat
ed Disc
Start Date: Oct/1/2
019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-09-2020
18:40:22
(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
Sep-09-2020
18:40:22
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Herniated DiscInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988437
Page 89 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-09-2020
18:40:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-09-2020
18:40:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-11-2020
10:45:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:VasectomyInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988438
Page 90 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Start Date
:UNK/UN
K/2014
Ongoing: NO
End Date
:
UNK/U
NK/201
4
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988439
Page 91 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b Line/MH Number:
Date Location User Value Reason
Sep-11-2020
10:45:11
(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
Sep-11-2020
10:45:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VasectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-11-2020
10:45:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988440
Page 92 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-11-2020
10:45:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988441
Page 93 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
170.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988442
Page 94 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.4Initial Entry
7.a
Date Location User Value Reason
Sep-09-2020
18:41:01ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988443
Page 95 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)Record Id
entifier::1
Temperat
ure:99.4
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
99.4Initial Entry
7.a Unit:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988444
Page 96 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020
18:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988445
Page 97 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020
18:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020
18:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
85740Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988446
Page 98 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
18:41:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
18:41:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
10:32:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-10-2020 ACV0PFEINFP6000  Query 1: Opened 'Sample
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988447
Page 99 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
04:07:42
(UTC-05:00)
Eastern Time (US
& Canada)Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-09-2020
18:41:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-09-2020
18:41:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
10:32:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWL3
WInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988448
Page 100 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
10:32:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWL3WInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020
10:32:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNWL3
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020
10:32:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWL3XInitial Entry
5.c
Date Location User Value Reason
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988449
Page 101 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-10-2020
10:32:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYM3
RInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020
10:32:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYM3RInitial Entry
5.d
Date Location User Value Reason
Sep-10-2020
10:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNWL3
MInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988450
Page 102 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Sep-10-2020
10:32:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWL3MInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988451
Page 103 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
18:41:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
18:41:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
10:31:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-10-2020 ACV0PFEINFP6000  Query 1: Opened 'Sample
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988452
Page 104 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
04:07:57
(UTC-05:00)
Eastern Time (US
& Canada)Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-09-2020
18:41:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-09-2020
18:41:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
10:31:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYM3
KInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988453
Page 105 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
10:31:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYM3KInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988454
Page 106 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020
18:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020
18:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020
18:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988455
Page 107 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-09-2020
18:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020 17:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020
18:42:27
(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-09-2020
18:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020
18:42:27
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988456
Page 108 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020
18:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-09-2020
18:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988457
Page 109 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-09-2020
18:42:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988458
Page 110 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020
20:24:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988459
Page 111 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020
20:24:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020
20:24:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:98.3
Temperat
ure Unit:F
Temperat
ure Locat
ion::ORAL
CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988460
Page 112 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-30-2020
20:24:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020
20:24:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020
20:24:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020
20:24:23
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988461
Page 113 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988462
Page 114 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
17:12:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
17:12:42
(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-30-2020
17:12:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988463
Page 115 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
17:12:42
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-30-2020
17:12:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020
17:12:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYN3PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020
17:12:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYN3PInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988464
Page 116 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020
20:25:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020
20:25:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020
20:25:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988465
Page 117 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-30-2020
20:25:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020 16:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020
20:25:33
(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-30-2020
20:25:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-30-2020
20:25:33
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988466
Page 118 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020
20:25:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-30-2020
20:25:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988467
Page 119 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020
07:13:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-30-2020
10:24:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edChanged data
per query
Oct-30-2020
05:23:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988468
Page 120 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
CRF and
update date of
EOT to match
date of blood
sample
collection date
at visit 3.
Oct-28-2020
15:54:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988469
Page 121 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
15:54:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
15:54:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
18:06:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988470
Page 122 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
15:54:59
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-28-2020
15:54:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020
18:06:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRC01
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020
18:06:02
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BRC016Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988471
Page 123 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
5.b
Date Location User Value Reason
Oct-28-2020
18:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSMGW
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020
18:13:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSMGW7Initial Entry
5.c
Date Location User Value Reason
Oct-28-2020
18:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSMGW
4Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988472
Page 124 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Sample ID
Date Location User Value Reason
Oct-28-2020
18:13:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSMGW4Initial Entry
5.d
Date Location User Value Reason
Oct-28-2020
18:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BSMGW
3Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-28-2020
18:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSMGW3Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988473
Page 125 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020
10:23:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
10:23:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
10:23:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988474
Page 126 of 162
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0988475
Page 127 of 162
***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
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021
18:26:38
(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
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Swollen lymph nodes
neck area (left side )Initial Entry
4. Start Date Time:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0988476
Page 128 of 162
***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
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/5/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988477
Page 129 of 162
***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
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-05-2021
18:26:38
(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
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988478
Page 130 of 162
***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
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021
18:26:38
(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
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988479
Page 131 of 162
***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
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021
18:26:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988480
Page 132 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
07:35:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-24-2021
19:41:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edNew
Information
Feb-24-2021
19:41:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021New
Information
Feb-24-2021
17:35:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Please verify
if the date of
subject
confirmation
to unblinded
was on
06Jan2021.
Update CRF
as needed.
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988481
Page 133 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-12-2021
16:50:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/11/2021Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988482
Page 134 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021
16:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loc
al/national reco
mmendations a
nd confirmed to
have received o
nly placebo at
Vaccination 1/2Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988483
Page 135 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021
17:15:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988484
Page 136 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-14-2021
17:15:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Co
nsent Obtained
Jan/14/2021Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988485
Page 137 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-14-2021
17:15:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-14-2021
17:15:34
(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-14-2021
17:15:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988486
Page 138 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-14-2021
17:15:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-14-2021
17:15:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-14-2021
17:16:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-14-2021 ACV0PFEINFP6000  auto query Query 1: Candida 'Sample
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988487
Page 139 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
17:15:43
(UTC-05:00)
Eastern Time
(US & Canada)(autoquery) te Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-14-2021
17:15:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-14-2021
17:16:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVRYJInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-14-2021
17:16:33
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BPVRYJInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0988488
Page 140 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
5.b
Date Location User Value Reason
Jan-14-2021
17:16:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS1GX
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-14-2021
17:16:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS1GXCInitial Entry
5.c
Date Location User Value Reason
Jan-14-2021
17:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS1GX
BInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0988489
Page 141 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Sample ID
Date Location User Value Reason
Jan-14-2021
17:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS1GXBInitial Entry
5.d
Date Location User Value Reason
Jan-14-2021
17:17:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS1GW
JInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-14-2021
17:17:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS1GWJInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0988490
Page 142 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-14-2021
17:15:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-14-2021
17:15:52
(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-14-2021
17:16:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-14-2021 ACV0PFEINFP6000  auto query Query 1: Candida 'Sample
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988491
Page 143 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
17:15:52
(UTC-05:00)
Eastern Time
(US & Canada)(autoquery) te Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-14-2021
17:15:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-14-2021
17:16:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPVRY
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-14-2021
17:16:20
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BPVRYKInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0988492
Page 144 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988493
Page 145 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988494
Page 146 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021 15:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-14-2021
17:16:14
(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-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988495
Page 147 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
8. Actual Dose:
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988496
Page 148 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
investigational product administration?
Date Location User Value Reason
Jan-14-2021
17:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988497
Page 149 of 162
***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-12-2021
16:50:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-12-2021
16:50:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBI
LITY FOR ADDI
TIONAL VACCI
NATIONInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988498
Page 150 of 162
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021
19:33:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988499
Page 151 of 162
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021
17:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021
17:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021
17:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-04-2021 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988500
Page 152 of 162
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
17:08:55
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-04-2021
17:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021
17:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVS2ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021
17:09:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPVS2ZInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0988501
Page 153 of 162
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988502
Page 154 of 162
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021 15:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988503
Page 155 of 162
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
8. Actual Dose:
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988504
Page 156 of 162
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
investigational product administration?
Date Location User Value Reason
Feb-04-2021
19:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988505
Page 157 of 162
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021
18:22:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988506
Page 158 of 162
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-05-2021
18:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-05-2021
18:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/5/2021Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988507
Page 159 of 162
***Confidential***
 
Header Text: C4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-05-2021
18:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-05-2021
18:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREAT
MENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-05-2021
18:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0988508
Page 160 of 162
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-30-2020
10:23:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-09-2020
18:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-09-2020
18:39:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-30-2020
10:23:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/28/2020Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988509
Page 161 of 162
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-09-2020
18:41:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/9/2020Initial Entry
Sep-09-2020
18:39:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/9/2020Initial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988510
Page 162 of 162
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
10:43:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Ena
bleInitial Entry
090177e196ae2f81\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988511