Document text
Page 1 of 144
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988206
Page 2 of 144
***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: 12041023 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/1/2020
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988207
Page 3 of 144
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12041023]
2.Birth Date: 1975
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988208
Page 4 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988209
Page 5 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 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
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988210
Page 6 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988211
Page 7 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988212
Page 8 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [150.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [22.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988213
Page 9 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [75951]
3.Randomization Group: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988214
Page 10 of 144
***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: 12041023 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/1/2020
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 [BNWL7T]
5.bSample ID [BNWL7X]
5.cSample ID [BPYLZX]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988215
Page 11 of 144
***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: 12041023 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/1/2020
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 [BPYM00]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988216
Page 12 of 144
***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: 12041023 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/1/2020 15:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988217
Page 13 of 144
***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: 12041023 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
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988218
Page 14 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988219
Page 15 of 144
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988220
Page 16 of 144
***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: 12041023 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/22/2020
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 [BPYN0J]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988221
Page 17 of 144
***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: 12041023 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/22/2020 14:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988222
Page 18 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988223
Page 19 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BRC024]
5.bSample ID [BSMGN9]
5.cSample ID [BSMGPG]
5.dSample ID [BSMGN6]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988224
Page 20 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988225
Page 21 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988226
Page 22 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988227
Page 23 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988228
Page 24 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988229
Page 25 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988230
Page 26 of 144
***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: 12041023 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:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988231
Page 27 of 144
***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: 12041023 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: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988232
Page 28 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988233
Page 29 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988234
Page 30 of 144
***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: 12041023 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?
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988235
Page 31 of 144
***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: 12041023 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:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988236
Page 32 of 144
***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: 12041023 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:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988237
Page 33 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988238
Page 34 of 144
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988239
Page 35 of 144
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988240
Page 36 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988241
Page 37 of 144
***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: 12041023 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: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988242
Page 38 of 144
***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: 12041023 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:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988243
Page 39 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988244
Page 40 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Pain at injection site Sep/1/2020
18:00 NO
End Date Time:
Sep/2/2020 UNK:U
NK
Repeating
Pages
2.ADVERSE
EVENT 2 Subjective Fever Sep/1/2020
17:00 NO
End Date Time:
Sep/2/2020 UNK:U
NK
Repeating
Pages
3.ADVERSE
EVENT 3 swollen lymph node g
land on neck Sep/1/2020
17:00 NO
End Date Time:
Sep/3/2020 UNK:U
NK
Repeating
Pages
4.ADVERSE
EVENT 4 chills Sep/23/202
0 08:00 NO
End Date Time:
Sep/24/2020 08:00
Repeating
Pages
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988245
Page 41 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 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)[Pain at injection site]
4.Start Date Time: Sep/1/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988246
Page 42 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988247
Page 43 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 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)[Subjective Fever]
4.Start Date Time: Sep/1/2020 17:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/2/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988248
Page 44 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988249
Page 45 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 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)[swollen lymph node gland on neck]
4.Start Date Time: Sep/1/2020 17:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/3/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988250
Page 46 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988251
Page 47 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 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)[chills]
4.Start Date Time: Sep/23/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/24/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988252
Page 48 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988253
Page 49 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988254
Page 50 of 144
***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: 12041023 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[ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988255
Page 51 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988256
Page 52 of 144
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988257
Page 53 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988258
Page 54 of 144
***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: 12041023 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?
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988259
Page 55 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988260
Page 56 of 144
***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: 12041023 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?
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988261
Page 57 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988262
Page 58 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988263
Page 59 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988264
Page 60 of 144
***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: 12041023 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:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988265
Page 61 of 144
***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: 12041023 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?
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988266
Page 62 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988267
Page 63 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988268
Page 64 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988269
Page 65 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988270
Page 66 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988271
Page 67 of 144
***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: 12041023 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 [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988272
Page 68 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988273
Page 69 of 144
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 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
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988274
Page 70 of 144
***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: 12041023 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
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988275
Page 71 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988276
Page 72 of 144
***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: 12041023 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: [ ]
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988277
Page 73 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988278
Page 74 of 144
***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: 12041023 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
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988279
Page 75 of 144
***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: 12041023 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
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988280
Page 76 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormSep-01-2020 17:23:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988281
Page 77 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormSep-01-2020 17:24:17 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988282
Page 78 of 144
***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: 12041023 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 12:49:21 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-27-2020 13:21:09 (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.
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988283
Page 79 of 144
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 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-01-2020
17:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-01-2020
17:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988284
Page 80 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020
17:22:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent O
btained
Sep/1/2020Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988285
Page 81 of 144
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 17:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12041023Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020
17:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020
17:22:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020
17:22:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANI
SH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988286
Page 82 of 144
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-01-2020
17:22:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988287
Page 83 of 144
***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: 12041023 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-01-2020
17:23:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988288
Page 84 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 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-01-2020
17:23:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 17:23:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020
17:23:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988289
Page 85 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
150.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988290
Page 86 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020 17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.1Initial Entry
7.a
Date Location User Value Reason
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identi
fier::1
Temperature: 99.9
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020 ACV0PFEINFP6000 Query 1: Closed Response
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988291
Page 87 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
02:05:27
(UTC-05:00)
Eastern Time (US &
Canada)satisfies query
Sep-03-2020
11:33:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered NCS
Sep-03-2020
01:14:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Reissued:Open
edDM 1: Please
confirm the
Temperature
99.9 F recorded
is clinically
significant or
not. Thank you.
Sep-01-2020
17:26:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Sep-01-2020
17:25:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature
99.9 F is outside
of Normal
Range 97 - 99.5
F.
Sep-01-2020
17:25:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
99.9Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988292
Page 88 of 144
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
17:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988293
Page 89 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020
18:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020
18:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
75951Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988294
Page 90 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 17:25:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 17:25:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
18:12:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
17:25:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-01-2020
17:25:26
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988295
Page 91 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US &
Canada) Sep/1/2020
5.a
Date Location User Value Reason
Sep-01-2020
18:12:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWL7TInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
18:12:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWL7TInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020
18:12:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWL7XInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020
18:12:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWL7XInitial Entry
5.c
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988296
Page 92 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-01-2020
18:12:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYLZXInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020
18:12:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYLZXInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988297
Page 93 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 17:25:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 17:25:40
(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-01-2020
18:13:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
17:25:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-01-2020
17:25:40
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988298
Page 94 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US &
Canada) Sep/1/2020
5.a
Date Location User Value Reason
Sep-01-2020
18:13:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYM00Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
18:13:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYM00Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988299
Page 95 of 144
***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: 12041023 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-01-2020
17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020
17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 15:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 17:26:13 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988300
Page 96 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) DELTOID MUSCLE
6. Body Side:
Date Location User Value Reason
Sep-01-2020
17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020 17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020 17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-01-2020
17:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988301
Page 97 of 144
***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: 12041023 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-01-2020
17:26:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLL
ECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988302
Page 98 of 144
***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: 12041023 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-22-2020
15:01:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0988303
Page 99 of 144
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
15:01:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
15:01:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:98.8
Temperatur
e Unit:F
Temperatur
e Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
15:01:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988304
Page 100 of 144
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-22-2020
15:01:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
15:01:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
15:01:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988305
Page 101 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 15:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 15:02:37
(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-22-2020
16:51:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
15:02:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-22-2020
15:02:37
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988306
Page 102 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada) Sep/22/2020
5.a
Date Location User Value Reason
Sep-22-2020
16:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYN0JInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
16:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYN0JInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988307
Page 103 of 144
***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: 12041023 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-22-2020
15:55:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 15:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 15:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020
15:55:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020 14:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988308
Page 104 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-22-2020 15:55:10
(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-22-2020
15:55:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020 15:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 15:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-22-2020
15:55:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988309
Page 105 of 144
***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: 12041023 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-26-2020
15:21:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-26-2020
10:42:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Oct-24-2020
11:35:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened As per CRF
guidelines, the
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date
of EOT to
match the date
the Visit 3.
Oct-21-2020
16:43:13
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988310
Page 106 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988311
Page 107 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 16:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-24-2020
10:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji
Prabu RQuery 1: Closed Query raised in
hidden items
Oct-24-2020
07:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per CRF
guidelines, the
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date
of EOT to match
the date the Visit
3.
Oct-21-2020
16:43:23ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0988312
Page 108 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00) Eastern
Time (US & Canada)
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
18:18:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
16:43:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-21-2020
16:43:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
18:18:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRC024Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988313
Page 109 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-21-2020
18:18:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRC024Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020
18:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMGN9Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
18:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMGN9Initial Entry
5.c
Date Location User Value Reason
Oct-21-2020
18:19:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMGPGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
18:19:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMGPGInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988314
Page 110 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d
Date Location User Value Reason
Oct-21-2020 18:19:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMGN6Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-21-2020 18:19:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMGN6Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988315
Page 111 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020
10:42:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 10:42:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020
10:42:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988316
Page 112 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Sep-03-2020
16:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988317
Page 113 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Sep-03-2020
17:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988318
Page 114 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-13-2020 23:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988319
Page 115 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-21-2020
16:46:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988320
Page 116 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Sep-03-2020 16:48:44
(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-03-2020 16:48:44
(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-20-2020
10:21:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-13-2020
23:58:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Oct-07-2020
13:42:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened AE of swollen
gland is reported
in source. Please
confirm and
update EDC if
appropriate.
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988321
Page 117 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-03-2020
16:48:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Pain at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-10-2020
12:41:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-10-2020
12:41:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 18:00New
Information
Sep-03-2020
16:48:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Pain at
injection site:
Start Date is the
same as a
Vaccination
Date, but time is
not provided.
Please review
and update as
appropriate.
Sep-03-2020
16:48:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988322
Page 118 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-17-2020
14:12:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/2/2020 UNK:UN
KNew
Information
Sep-03-2020
16:48:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-03-2020
16:48:44
(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
Sep-03-2020
16:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988323
Page 119 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 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
Sep-03-2020
16:48:44
(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-03-2020
16:48:44
(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-03-2020
16:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-03-2020
16:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988324
Page 120 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-03-2020
16:48:44
(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-17-2020
14:13:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020
14:13:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDNew Information
Sep-17-2020
14:12:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Pain at
injection site:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-03-2020
16:48:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RE
SOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988325
Page 121 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-03-2020
16:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988326
Page 122 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Sep-03-2020 17:02:25
(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-03-2020 17:02:25
(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
Oct-14-2020
17:51:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Oct-13-2020
23:59:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Oct-13-2020
23:59:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Subjective FeverChanged
Information
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988327
Page 123 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-07-2020
13:44:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Opened Fever is defined
in protocol as
100.4 F. Source
states this fever
was 99.8 F.
Please confirm if
this should be
reported as an
AE.
Sep-17-2020
17:15:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Sep-17-2020
14:16:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Sep-17-2020
13:01:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Is
Fever still
ongoing? If yes,
Please complete
COVID Illness
visit CRFs and
collect Nasal
Swab ASAP.
Sep-03-2020
17:02:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988328
Page 124 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sep-10-2020
12:42:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-10-2020
12:42:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 17:00New
Information
Sep-03-2020
17:02:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Fever:
Start Date is the
same as a
Vaccination
Date, but time is
not provided.
Please review
and update as
appropriate.
Sep-03-2020
17:02:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020
10:27:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-15-2020
15:59:16ACV0PFEINFP6000 Query 1: Answered Clinician
evaluated that
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988329
Page 125 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US &
Canada)symptom is
vaccine-related
and within 7 days
of reactogenicity
so a COVID visit
is not needed
Oct-15-2020
11:55:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened CLIQUERY:
Please confirm if
the PI considered
SUBJECTIVE
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.
Sep-17-2020
14:15:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/2/2020 UNK:U
NKNew Information
Sep-03-2020
17:02:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988330
Page 126 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Sep-03-2020
17:02:25
(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
Sep-03-2020
17:02:25
(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-03-2020
17:02:25
(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-03-2020
17:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988331
Page 127 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-03-2020
17:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-03-2020
17:02:25
(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-03-2020
17:02:25
(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-17-2020
14:15:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020
14:15:34
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDNew Information
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988332
Page 128 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
Sep-17-2020
14:15:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Fever:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-03-2020
17:02:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RE
SOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-03-2020
17:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988333
Page 129 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 23:57:33
(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-13-2020 23:57:33
(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 ValueReason
Oct-15-2020
20:30:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Oct-15-2020
15:35:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged
Information
Oct-15-2020
15:35:18
(UTC-05:00)ACV0PFEINFP6000 Data
Entry
:Changed
Information
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0988334
Page 130 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time
(US &
Canada)swoll
en ly
mph n
ode gl
and o
n nec
k
Oct-14-2020
04:47:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify
SWOLLEN
GLAND ON
NECK as
follows...Term
is incomplete.
Are you
reporting
THYROID
GLAND?
LYMPH
GLAND?
Other? Please
update the
verbatim term
to clarify.
Thank you.
Oct-13-2020
23:57:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
swoll
en gla
nd on
neckInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020 23:57:33
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sep/1/2020 17:00Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0988335
Page 131 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020
18:34:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-23-2020
09:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-23-2020
09:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/3/2020 UNK:U
NKChanged
Information
Oct-22-2020
21:13:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Per source end
date is
03Sep2020
please confirm
and update if
applicable.
Oct-13-2020
23:57:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988336
Page 132 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-13-2020 23:57:33
(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-13-2020 23:57:33
(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-13-2020 23:57:33
(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-13-2020 23:57:33
(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-13-2020 23:57:33 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988337
Page 133 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00) Eastern
Time (US & Canada)NOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 23:57:33
(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-13-2020 23:57:33
(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-23-2020
09:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-23-2020
09:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/R
ESOLVEDChanged Information
Oct-23-2020
09:19:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE swollen lymph
node gland on neck:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988338
Page 134 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
but AE End Date/Time
is present.
Oct-13-2020
23:57:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/R
ESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 23:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988339
Page 135 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020 16:46:26
(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-21-2020 16:46:26
(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-21-2020
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-21-2020
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988340
Page 136 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-21-2020
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/24/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-21-2020
16:46:26
(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-21-2020
16:46:26
(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-21-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988341
Page 137 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)NO
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020
16:46:26
(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-21-2020
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-21-2020
16:46:26
(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-21-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988342
Page 138 of 144
***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, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)NO
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-21-2020
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-21-2020
16:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988343
Page 139 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
12:49:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0988344
Page 140 of 144
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
12:50:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to ret
urn for Vaccination 3
Participant is:
eligible and NOT confi
rmed to have received
only placebo at Vaccina
tion 1/2Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0988345
Page 141 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021
12:49:46
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021Transcription
Error
Feb-18-2021
12:49:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-18-2021
12:49:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACC
INATIONInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0988346
Page 142 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020 10:42:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-01-2020 18:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Sep-01-2020 17:23:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-05-2021
02:13:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-04-2021
16:47:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Participant
reported COVID
symptom,
confirmed to be
not COVID
related.
Therefore, no
COVID illness
visit needed.
Raised DCF via
trial manager on
3/2/2021
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988347
Page 143 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-26-2021
15:21:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Illness eDiary:
Subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
23FEB2021.
But there is no
COVID Illness
visit reported in
the database.
Please clarify.
Oct-26-2020
10:42:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Sep-01-2020
18:12:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
Sep-01-2020
17:23:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988348
Page 144 of 144
***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: 12041023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
10:24:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f82\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988349