125742 S1 M5 CRF c4591001 1204 12041138

Document text

Page 1 of 195
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 12041138 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 version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988512
Page 2 of 195
***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: 12041138 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/21/2020
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988513
Page 3 of 195
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12041138]
2.Birth Date: 1988
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988514
Page 4 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988515
Page 5 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988516
Page 6 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988517
Page 7 of 195
***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: 12041138 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:[Pernicious Anemia]
Start Date: Mar/21/2019
Ongoing: YES
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988518
Page 8 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988519
Page 9 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
2.Weight: [140.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [19.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988520
Page 10 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/21/2020
2.Randomization Number: [95019]
3.Randomization Group: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988521
Page 11 of 195
***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: 12041138 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/21/2020
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 [BPYM8F]
5.bSample ID [BNWLC0]
5.cSample ID [BNWLC4]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988522
Page 12 of 195
***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: 12041138 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/21/2020
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 [BPYM8B]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988523
Page 13 of 195
***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: 12041138 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/21/2020 15:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988524
Page 14 of 195
***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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988525
Page 15 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988526
Page 16 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988527
Page 17 of 195
***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: 12041138 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:
Oct/12/2020
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 [BPYNBT]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988528
Page 18 of 195
***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: 12041138 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: Oct/12/2020 12:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988529
Page 19 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988530
Page 20 of 195
***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: 12041138 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:
Nov/16/2020
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 [BPVRMD]
5.bSample ID [BRV5DV]
5.cSample ID [BRV5DX]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988531
Page 21 of 195
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988532
Page 22 of 195
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988533
Page 23 of 195
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988534
Page 24 of 195
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988535
Page 25 of 195
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988536
Page 26 of 195
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988537
Page 27 of 195
***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: 12041138 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:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988538
Page 28 of 195
***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: 12041138 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: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988539
Page 29 of 195
***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: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988540
Page 30 of 195
***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: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988541
Page 31 of 195
***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: 12041138 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?
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988542
Page 32 of 195
***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: 12041138 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:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988543
Page 33 of 195
***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: 12041138 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:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988544
Page 34 of 195
***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: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988545
Page 35 of 195
***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: 12041138 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:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988546
Page 36 of 195
***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: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988547
Page 37 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988548
Page 38 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988549
Page 39 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  muscle pain - abdo
minal Sep/22/20
20 20:00 NO
End Date Time:
Sep/23/2020 22:0
0
 Repeating
Pages
 2.ADVERS
E EVENT 2  opposite shoulder p
ain intermittent Sep/22/20
20 12:00 NO
End Date Time:
Sep/23/2020 10:0
0
 Repeating
Pages
 3.ADVERS
E EVENT 3  Muscle tenderness
at injection site Oct/12/20
20 22:00 NO
End Date Time:
Oct/14/2020 09:0
0
 Repeating
Pages
 4.ADVERS
E EVENT 4  Low grade fever, 99
.0 Oct/13/20
20 12:00 NO
End Date Time:
Oct/14/2020 09:0
0
 Repeating
Pages
 5.ADVERS
E EVENT 5  Fatigue  Oct/12/20
20 22:00 NO
End Date Time:Repeating
Pages
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988550
Page 40 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
Oct/14/2020 09:0
0
 
 6.ADVERS
E EVENT 6  Swollen submandib
ular lymph nodes Oct/13/20
20 20:00 NO
End Date Time:
Oct/15/2020 UN
K:UNK
 Repeating
Pages
 7.ADVERS
E EVENT 7  Polydipsia  Oct/12/20
20 22:00 NO
End Date Time:
Oct/15/2020 UN
K:UNK
 Repeating
Pages
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988551
Page 41 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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)[muscle pain - abdominal]
4.Start Date Time: Sep/22/2020 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/23/2020 22:00
6.Toxicity Grade: 1
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988552
Page 42 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988553
Page 43 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988554
Page 44 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[opposite shoulder pain intermittent]
4.Start Date Time: Sep/22/2020 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/23/2020 10:00
6.Toxicity Grade: 1
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988555
Page 45 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[repetitive stress from work]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988556
Page 46 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988557
Page 47 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Muscle tenderness at injection site]
4.Start Date Time: Oct/12/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/14/2020 09:00
6.Toxicity Grade: 1
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988558
Page 48 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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?YES
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988559
Page 49 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988560
Page 50 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Low grade fever, 99.0]
4.Start Date Time: Oct/13/2020 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/14/2020 09:00
6.Toxicity Grade: 1
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988561
Page 51 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988562
Page 52 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988563
Page 53 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fatigue]
4.Start Date Time: Oct/12/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/14/2020 09:00
6.Toxicity Grade: 1
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988564
Page 54 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988565
Page 55 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988566
Page 56 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Swollen submandibular lymph nodes]
4.Start Date Time: Oct/13/2020 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/15/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988567
Page 57 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988568
Page 58 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988569
Page 59 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Polydipsia]
4.Start Date Time: Oct/12/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/15/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988570
Page 60 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988571
Page 61 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988572
Page 62 of 195
***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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988573
Page 63 of 195
***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: 12041138 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[ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988574
Page 64 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Influenza V
accine Oct/30/
2020 Repeating
Pages
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988575
Page 65 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Influenza Vaccine]
5.Date: Oct/30/2020
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988576
Page 66 of 195
***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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988577
Page 67 of 195
***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: 12041138 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?
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988578
Page 68 of 195
***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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988579
Page 69 of 195
***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: 12041138 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?
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988580
Page 70 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988581
Page 71 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988582
Page 72 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988583
Page 73 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988584
Page 74 of 195
***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: 12041138 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:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988585
Page 75 of 195
***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: 12041138 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?
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988586
Page 76 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988587
Page 77 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988588
Page 78 of 195
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988589
Page 79 of 195
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988590
Page 80 of 195
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988591
Page 81 of 195
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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 [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988592
Page 82 of 195
***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: 12041138 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: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988593
Page 83 of 195
***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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988594
Page 84 of 195
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988595
Page 85 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988596
Page 86 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988597
Page 87 of 195
***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: 12041138 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: [ ]
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988598
Page 88 of 195
***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: 12041138 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 Nov/16/2020
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988599
Page 89 of 195
***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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988600
Page 90 of 195
***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: 12041138 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
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988601
Page 91 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormSep-21-2020 16:48:23 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988602
Page 92 of 195
***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: 12041138 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-18-2021 19:10:13 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-16-2020 19:00:08 (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.
 N/A Nov-16-2020 15:54:38 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0988603
Page 93 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
N/A
 Approved Nov-06-2020 18:37:47 (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.
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988604
Page 94 of 195
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 12041138 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-21-2020
16:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-21-2020
16:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988605
Page 95 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-21-2020
16:45:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/21/2020Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988606
Page 96 of 195
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-21-2020
16:45:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12041138Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-21-2020
16:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1988Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-21-2020
16:45:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988607
Page 97 of 195
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-21-2020
16:45:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LAT
INO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-21-2020
16:45:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988608
Page 98 of 195
***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: 12041138 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-21-2020
16:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988609
Page 99 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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-21-2020
16:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-21-2020
16:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-21-2020
16:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988610
Page 100 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Sep-21-2020
16:50:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:Perniciou
s Anemia
Start Date: Mar/21/2
019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-21-2020
16:50:23
(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-21-2020
16:50:23ACV0PFEINFP6000  Data Entry:
Pernicious AnemiaInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988611
Page 101 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-21-2020
16:50:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/21/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-21-2020
16:50:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988612
Page 102 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-21-2020
16:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988613
Page 103 of 195
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
140.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae2f80\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-2021-5683-0988614
Page 104 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19.0Initial Entry
7.a
Date Location User Value Reason
Sep-21-2020
16:51:49ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f80\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-2021-5683-0988615
Page 105 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 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:98.7
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
7.a Unit:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988616
Page 106 of 195
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-21-2020
16:51:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988617
Page 107 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-21-2020
19:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-21-2020
19:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
95019Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988618
Page 108 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020
16:52:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020
16:52:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020
17:00:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-21-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988619
Page 109 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
16:52:22
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-21-2020
16:52:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020
17:00:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYM8
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020
17:00:22
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BPYM8FInitial Entry
090177e196ae2f80\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-2021-5683-0988620
Page 110 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
5.b
Date Location User Value Reason
Sep-21-2020
17:01:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNWLC
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-21-2020
17:01:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWLC0Initial Entry
5.c
Date Location User Value Reason
Sep-21-2020
17:01:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNWLC
4Initial Entry
090177e196ae2f80\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-2021-5683-0988621
Page 111 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Sample ID
Date Location User Value Reason
Sep-21-2020
17:01:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWLC4Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988622
Page 112 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020
16:52:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020
16:52:29
(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-21-2020
17:00:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-21-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988623
Page 113 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
16:52:29
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-21-2020
16:52:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020
17:00:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYM8
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020
17:00:06
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BPYM8BInitial Entry
090177e196ae2f80\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-2021-5683-0988624
Page 114 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988625
Page 115 of 195
***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: 12041138 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-21-2020
19:11:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020
19:11:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020
19:11:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988626
Page 116 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-21-2020
19:11:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020 15:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020
19:11:23
(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-21-2020
19:11:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020
19:11:23
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988627
Page 117 of 195
***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: 12041138 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-21-2020
19:11:23
(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-21-2020
19:11:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988628
Page 118 of 195
***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: 12041138 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-21-2020
19:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988629
Page 119 of 195
***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: 12041138 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-12-2020
15:22:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988630
Page 120 of 195
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-13-2020
08:48:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2.a
Date Location User Value Reason
Oct-13-2020
08:48:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:98.6
Temperat
ure Unit:F
Temperat
ure Locat
ion::ORAL
CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988631
Page 121 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-13-2020
08:48:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-13-2020
08:48:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-13-2020
08:48:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-13-2020
08:48:34
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f80\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-2021-5683-0988632
Page 122 of 195
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988633
Page 123 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
15:23:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
15:23:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
16:20:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020 ACV0PFEINFP6000  auto query Query 1: Candida 'Sample
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988634
Page 124 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
15:23:19
(UTC-05:00)
Eastern Time
(US & Canada)(autoquery) te Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-12-2020
15:23:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
16:20:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPYNB
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
16:20:17
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BPYNBTInitial Entry
090177e196ae2f80\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-2021-5683-0988635
Page 125 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988636
Page 126 of 195
***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: 12041138 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
Oct-13-2020
08:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-13-2020
08:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020
08:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988637
Page 127 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-13-2020
08:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020 12:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020
08:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-13-2020
08:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-13-2020
08:48:16
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988638
Page 128 of 195
***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: 12041138 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
Oct-13-2020
08:48:16
(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
Oct-13-2020
08:48:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988639
Page 129 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020
15:54:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/16/2020Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988640
Page 130 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-16-2020
15:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-16-2020
15:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-16-2020
17:14:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-16-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988641
Page 131 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
15:55:25
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-16-2020
15:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Nov/16/2020Initial Entry
5.a
Date Location User Value Reason
Nov-16-2020
17:14:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPVRM
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-16-2020
17:14:04
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BPVRMDInitial Entry
090177e196ae2f80\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-2021-5683-0988642
Page 132 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
5.b
Date Location User Value Reason
Nov-16-2020
17:14:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRV5D
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-16-2020
17:14:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRV5DVInitial Entry
5.c
Date Location User Value Reason
Nov-16-2020
17:14:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRV5D
XInitial Entry
090177e196ae2f80\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-2021-5683-0988643
Page 133 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Sample ID
Date Location User Value Reason
Nov-16-2020
17:14:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRV5DXInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988644
Page 134 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988645
Page 135 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988646
Page 136 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988647
Page 137 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988648
Page 138 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988649
Page 139 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988650
Page 140 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988651
Page 141 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-24-2020
12:20:51
(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
Oct-16-2020
10:32:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-15-2020 ACV0PFEINFP6000  Query 1: Answe Symptom is
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988652
Page 142 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
16:07:07
(UTC-05:00)
Eastern Time
(US & Canada)red evaluated by
clinician to be
within 7 days
of
reactogenicity
and not
COVID-related
Oct-15-2020
11:17:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dCLIQUERY:
Please confirm
if the PI
considered
MUSCLE
PAIN for
COVID related
illness?
COVID-19
symptoms
should trigger a
potential
COVID Illness
Visit and be
documented
ONLY on the
COVID Illness
SOD CRF
form and not
on the AE CRF
form.
Oct-15-2020
10:51:24
(UTC-05:00)ACV0PFEINFP6000  Query 1: Candid
ateCLIQUERY:
Please confirm
if the PI
090177e196ae2f80\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-2021-5683-0988653
Page 143 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time
(US & Canada)considered
MUSCLE
PAIN for
COVID related
illness?
COVID-19
symptoms
should trigger a
potential
COVID Illness
Visit and be
documented
ONLY on the
COVID Illness
SOD CRF
form and not
on the AE CRF
form.
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
muscle pain - ab
dominalInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sep/22/2020 20:00Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988654
Page 144 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/23/2020 22
:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988655
Page 145 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-24-2020
12:20:51ACV0PFEINFP6000  Data Entry:
NOT APPLICABInitial Entry
090177e196ae2f80\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-2021-5683-0988656
Page 146 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)LE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
090177e196ae2f80\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-2021-5683-0988657
Page 147 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-24-2020
12:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988658
Page 148 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
opposite shoulder
pain intermittentInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988659
Page 149 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020
16:20:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-12-2020
15:43:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edChanged
Information
Oct-12-2020
15:43:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/23/2020 1
0:00Changed
Information
Oct-08-2020 ACV0PFEINFP6000  Query 1: Opened ClinQuery:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988660
Page 150 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
13:54:15
(UTC-05:00)
Eastern Time
(US & Canada)Please advise,
is the event
still ongoing,
else please
provide an
end date.
Thanks
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae2f80\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-2021-5683-0988661
Page 151 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHER
If Other, specifInitial Entry
090177e196ae2f80\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-2021-5683-0988662
Page 152 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
y:
repetitive str
ess from wor
k
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\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-2021-5683-0988663
Page 153 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-14-2020
00:09:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: C
losedClose Auto Query
Oct-14-2020
00:09:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDTranscription Error
Oct-12-2020
15:43:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: O
penedFor AE opposite
shoulder pain
intermittent: Response
to "What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-29-2020
14:58:49
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 2: C
losedClose Auto Query
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988664
Page 154 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time
(US &
Canada)
Sep-29-2020
14:58:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RING/RES
OLVINGTranscription Error
Sep-29-2020
11:44:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: O
penedFor AE opposite
shoulder pain
intermittent: Response
to "What was the
outcome of this
adverse event?" is 3
but End Date/Time is
missing.
Sep-29-2020
11:44:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Sep-29-2020
11:44:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDTranscription Error
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988665
Page 155 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE opposite
shoulder pain
intermittent: Response
to "What was the
outcome of this
adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?" is
marked "Yes".
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
UNKNOW
NInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-28-2020
13:54:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988666
Page 156 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Muscle tenderness
at injection siteInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988667
Page 157 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/14/2020 09
:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae2f80\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-2021-5683-0988668
Page 158 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-14-2020
14:10:28
(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
Oct-14-2020
14:10:28
(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
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae2f80\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-2021-5683-0988669
Page 159 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2f80\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-2021-5683-0988670
Page 160 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020
14:10:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988671
Page 161 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020
10:33:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Within 7 days
of vaccination.
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988672
Page 162 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-16-2020
04:46:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY:
Please confirm
if the PI
considered
LOW GRADE
FEVER for
COVID
related illness?
COVID-19
symptoms
should trigger
a potential
COVID Illness
Visit and be
documented
ONLY on the
COVID Illness
SOD CRF
form and not
on the AE
CRF form.
Oct-15-2020
11:49:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Candid
ateCLIQUERY:
Please confirm
if the PI
considered
LOW GRADE
FEVER for
COVID
related illness?
COVID-19
symptoms
should trigger
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988673
Page 163 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
a potential
COVID Illness
Visit and be
documented
ONLY on the
COVID Illness
SOD CRF
form and not
on the AE
CRF form.
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Low grade fever,
99.0Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020
14:11:34ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\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-2021-5683-0988674
Page 164 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)End Date Time:
Oct/14/2020 09
:00
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae2f80\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-2021-5683-0988675
Page 165 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-14-2020
14:11:34
(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
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2f80\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-2021-5683-0988676
Page 166 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020
14:11:34
(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
Oct-14-2020
14:11:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020
14:11:34
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\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-2021-5683-0988677
Page 167 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988678
Page 168 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988679
Page 169 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/14/2020 09
:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae2f80\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-2021-5683-0988680
Page 170 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-14-2020
14:12:23
(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
Oct-14-2020
14:12:23
(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
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae2f80\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-2021-5683-0988681
Page 171 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2f80\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-2021-5683-0988682
Page 172 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020
14:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988683
Page 173 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Swollen submandi
bular lymph nodesInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988684
Page 174 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-20-2020
10:57:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/15/2020
UNK:UNKChanged
Information
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f80\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-2021-5683-0988685
Page 175 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-14-2020
14:13:23
(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
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988686
Page 176 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020
14:13:23ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\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-2021-5683-0988687
Page 177 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-20-2020
16:52:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Oct-20-2020
16:52:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDNew Information
Oct-20-2020
10:57:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Swollen
submandibular lymph
nodes: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-14-2020
14:13:23ACV0PFEINFP6000  Data Entr
y:Initial Entry
090177e196ae2f80\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-2021-5683-0988688
Page 178 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time
(US &
Canada)RECOVE
RING/RES
OLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020
14:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988689
Page 179 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PolydipsiaInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988690
Page 180 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-15-2020
12:36:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/15/2020
UNK:UNKChanged
Information
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae2f80\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-2021-5683-0988691
Page 181 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-14-2020
14:14:11
(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
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988692
Page 182 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020
14:14:11ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\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-2021-5683-0988693
Page 183 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-15-2020
12:37:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Oct-15-2020
12:37:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDChanged Information
Oct-15-2020
12:36:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Polydipsia:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data Entr
y:
RECOVE
RING/RESInitial Entry
090177e196ae2f80\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-2021-5683-0988694
Page 184 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(US &
Canada)OLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020
14:14:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988695
Page 185 of 195
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-16-2020
15:55:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988696
Page 186 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-16-2020
15:55:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-16-2020
15:55:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-16-2020
15:55:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988697
Page 187 of 195
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Provide the complete generic drug name (including salt form, where applicable). Where generic
name is unknown, enter the full trade or proprietary name. Include clarifying information in
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-16-2020
15:55:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Influenza VaccineInitial Entry
5. Date:
Date Location User Value Reason
Nov-16-2020
15:55:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988698
Page 188 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-16-2020
15:56:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-16-2020
15:56:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-16-2020
15:56:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988699
Page 189 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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1. Date of Visit
Date Location User Value Reason
Feb-18-2021
19:10:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0988700
Page 190 of 195
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
19:10:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
19:10:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-18-2021
19:10:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed toInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0988701
Page 191 of 195
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
have received o
nly placebo at V
accination 1/2
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988702
Page 192 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021
19:10:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-18-2021
19:10:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0988703
Page 193 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-16-2020
15:56:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-21-2020
19:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-21-2020
16:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-16-2020
15:56:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/16/2020Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988704
Page 194 of 195
***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: 12041138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-21-2020
19:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
Sep-21-2020
16:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988705
Page 195 of 195
***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: 12041138 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
11:01:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Ena
bleInitial Entry
090177e196ae2f80\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988706