125742 S1 M5 CRF c4591001 1204 12041280

Document text

Page 1 of 143
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988917
Page 2 of 143
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
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: 12041280 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
Oct/21/2020
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988918
Page 3 of 143
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12041280]
2.Birth Date: 1979
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988919
Page 4 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988920
Page 5 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988921
Page 6 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988922
Page 7 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Stress fracture ( Sacrum area)]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2020
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988923
Page 8 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988924
Page 9 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
2.Weight: [177.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [28.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988925
Page 10 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/21/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988926
Page 11 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/21/2020
2.Randomization Number: [111624]
3.Randomization Group: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988927
Page 12 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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 [BRC028]
5.bSample ID [BSMGMV]
5.cSample ID [BSMGNC]
5.dSample ID [BSMGNB]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988928
Page 13 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/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 [BRC02F]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988929
Page 14 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/21/2020 16:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988930
Page 15 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988931
Page 16 of 143
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988932
Page 17 of 143
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988933
Page 18 of 143
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/13/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988934
Page 19 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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:
Nov/13/2020
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 [BPVRM1]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988935
Page 20 of 143
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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: Nov/13/2020 15:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988936
Page 21 of 143
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988937
Page 22 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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:
Dec/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS5HMH]
5.bSample ID [BS5HMK]
5.cSample ID [BS5HMJ]
5.dSample ID [BPVRRX]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988938
Page 23 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988939
Page 24 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988940
Page 25 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988941
Page 26 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988942
Page 27 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988943
Page 28 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988944
Page 29 of 143
***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: 12041280 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:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988945
Page 30 of 143
***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: 12041280 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: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988946
Page 31 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988947
Page 32 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988948
Page 33 of 143
***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: 12041280 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?
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988949
Page 34 of 143
***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: 12041280 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:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988950
Page 35 of 143
***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: 12041280 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:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988951
Page 36 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988952
Page 37 of 143
***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: 12041280 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:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988953
Page 38 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988954
Page 39 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Drug Exposure During P
regnancy Oct/1/2020 UNK:
UNK NO
End Date Time:
Nov/9/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE E
VENT 2  Medication abortion  Nov/9/2020 UNK
:UNK NO
End Date Time:
Nov/9/2020 UNK:UNK
 Repeating
Pages
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988955
Page 40 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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)[Drug Exposure During Pregnancy]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pregnancy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988956
Page 41 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988957
Page 42 of 143
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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)[Medication abortion]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pregnancy]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988958
Page 43 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988959
Page 44 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988960
Page 45 of 143
***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: 12041280 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[ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988961
Page 46 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medicatio
nStart D
ateForm Instanc
e
 1.1  VACCINATIONS
 NO  Moderna COVID-19
Vaccine Feb/4/2
021 Repeating
Pages
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988962
Page 47 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Moderna COVID-19 Vaccine]
5.Date: Feb/4/2021
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988963
Page 48 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988964
Page 49 of 143
***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: 12041280 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?
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988965
Page 50 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988966
Page 51 of 143
***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: 12041280 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?
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988967
Page 52 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988968
Page 53 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988969
Page 54 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988970
Page 55 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988971
Page 56 of 143
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988972
Page 57 of 143
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988973
Page 58 of 143
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988974
Page 59 of 143
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12041280 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?
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988975
Page 60 of 143
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988976
Page 61 of 143
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988977
Page 62 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988978
Page 63 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988979
Page 64 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988980
Page 65 of 143
***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: 12041280 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 [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988981
Page 66 of 143
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988982
Page 67 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/6/2021
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988983
Page 68 of 143
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Answered Queries
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988984
Page 69 of 143
***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: 12041280 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: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988985
Page 70 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988986
Page 71 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988987
Page 72 of 143
***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: 12041280 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: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988988
Page 73 of 143
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988989
Page 74 of 143
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988990
Page 75 of 143
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988991
Page 76 of 143
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988992
Page 77 of 143
***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: 12041280 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 Dec/16/2020
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988993
Page 78 of 143
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988994
Page 79 of 143
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988995
Page 80 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-21-2020 16:49:39 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988996
Page 81 of 143
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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 13:06:51 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Judith Aberg  Approved Jan-25-2021 16:46:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JudithAberg, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988997
Page 82 of 143
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
Oct-21-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-21-2020 16:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988998
Page 83 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-21-2020 16:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/21/2020Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988999
Page 84 of 143
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-21-2020 16:48:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12041280Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-21-2020 16:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-21-2020 16:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-21-2020 16:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-21-2020 16:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989000
Page 85 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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-21-2020 16:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989001
Page 86 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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-21-2020 16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989002
Page 87 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020 16:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Stress fracture ( Sa
crum area)
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/202
0Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-21-2020 16:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 16:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Stress fracture ( Sacrum area)Initial Entry
1.a Start Date:
Date Location User Value Reason
Oct-21-2020 16:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-21-2020 16:50:45 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f84\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-2021-5683-0989003
Page 88 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00) Eastern
Time (US & Canada)NO
End Date:
UNK/UNK/2020
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989004
Page 89 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-21-2020 16:51:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989005
Page 90 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
177.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.6Initial Entry
090177e196ae2f84\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-2021-5683-0989006
Page 91 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.a
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 99.0
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-21-2020 16:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f84\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-2021-5683-0989007
Page 92 of 143
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989008
Page 93 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-21-2020 16:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989009
Page 94 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-21-2020 17:59:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-21-2020 17:59:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
111624Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989010
Page 95 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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 16:52:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 16:52:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 17:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 16:52:13
(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 16:52:13
(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 17:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRC028Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989011
Page 96 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 17:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRC028Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020 18:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSMGMVInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 18:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSMGMVInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 18:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSMGNCInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 18:36:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSMGNCInitial Entry
5.d
Date Location User Value Reason
Oct-21-2020 18:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSMGNBInitial Entry
090177e196ae2f84\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989012
Page 97 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Oct-21-2020 18:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSMGNBInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989013
Page 98 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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 16:51:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 16:51:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 16:52:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 16:51:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-21-2020 16:51:55
(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 16:52:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRC02FInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989014
Page 99 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 16:52:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRC02FInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989015
Page 100 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020 16:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2f84\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-2021-5683-0989016
Page 101 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Oct-21-2020 18:00:31
(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
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-21-2020 18:00:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989017
Page 102 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
Oct-21-2020 18:00:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989018
Page 103 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020 16:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989019
Page 104 of 143
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-13-2020 16:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
2.a
Date Location User Value Reason
Nov-13-2020 16:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-13-2020 16:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-13-2020 16:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-13-2020 16:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2f84\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-2021-5683-0989020
Page 105 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.a Temperature Location:
Date Location User Value Reason
Nov-13-2020 16:46:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989021
Page 106 of 143
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989022
Page 107 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: POSITIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-13-2020 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-19-2021
11:50:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Clos
edResponse satisfies
query
Feb-19-2021
08:38:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Ans
weredTermination
confirmed by
sonogram on Nov 13;
however, as said
before, urine
pregnancy tests after
an abortion will still
show up as positive
as HcG is still in the
body in high levels
and will show up on
a pregnancy test.
090177e196ae2f84\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-2021-5683-0989023
Page 108 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-19-2021
07:01:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Reis
sued:O
penedDM : Per response,
'Participant had
medication abortion
on November 9,
2020 and confirmed
completion via
sonogram done
November 13,2020.'
However, Test result
is still POSITIVE for
sample collected on
13/Nov/2020. Please
update or clarify.
Feb-18-2021
16:56:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
5: Clos
edResponse satisfies
query
Feb-18-2021
13:10:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
5: Ans
weredPregnancy recorded
as AE
Feb-16-2021
14:30:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
5: Ope
nedCLINQUERY:
Patient has
pregnancy between
vax 1 and vax 2
which was
terminated, this
needs to be recorded
on the AE Log with
stop date being date
of termination.
Jan-22-2021
09:37:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Reis
sued:C
andidat
eTo be reviewed per
site response
provided
Jan-21-2021
09:24:33ACV0PFEINFP6000  Query
4: AnsUrine pregnancy
tests after an abortion
090177e196ae2f84\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989024
Page 109 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time
(US &
Canada)wered will still show up as
positive as HcG is
still in the body and
will show up on a
pregnancy test.
Usually must wait
3-4 weeks after an
abortion to receive a
negative test.
Jan-18-2021
01:23:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Ope
nedDM : Per response,
'Participant had
medication abortion
on November 9,
2020 and confirmed
completion via
sonogram done
November 13,2020.'
However, Test result
is still POSITIVE for
sample collected on
13/Nov/2020. Please
update or clarify.
Jan-18-2021
01:20:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clos
edResponse satisfies
query
Jan-15-2021
10:35:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredParticipant had
medication abortion
on November 9,
2020 and confirmed
completion via
sonogram done
November 13,2020.
PI confirmed that
vaccination 2 could
be administered and
participant eligible
for continuation in
study.
Jan-15-2021
04:54:40ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: OpeDMW6841729;There
is a pregnancy test
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989025
Page 110 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time
(US &
Canada)ned with a positive result,
but there is no
disposition eCRF
with a 'Status' of
PREGNANCY with
a disposition date on
or after the
pregnancy test date.
Please review and
update as
appropriate.
Nov-13-2020
23:52:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edClosed per SITE
response, added to
PD tracker
Nov-13-2020
23:51:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clos
edClosed per SITE
response, added to
PD tracker
Nov-13-2020
18:00:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredParticipant had
medication abortion
on November 9,
2020, and the
confirmed
completion via
sonogram was done
today, November 13,
2020. Confirmed
with PI Dr. Aberg
that vaccination #2
can be administered
Nov-13-2020
17:59:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Ope
nedLab result is
“Positive”, but
subject has been
vaccinated. Please
review and update as
appropriate. Else
explain.
090177e196ae2f84\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-2021-5683-0989026
Page 111 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-13-2020
16:50:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredParticipant had
medication abortion
on November 9,
2020, and the
confirmed
completion via
sonogram was done
today, November 13,
2020. Confirmed
with PI Dr. Aberg
that vaccination #2
can be administered.
Nov-13-2020
16:47:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ope
nedLab result is
“Positive”, but
subject has been
vaccinated. Please
review and update as
appropriate. Else
explain.
Nov-13-2020
16:47:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
POSITI
VEInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989027
Page 112 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 16:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 16:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 17:31:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 16:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-13-2020 16:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 17:31:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVRM1Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989028
Page 113 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 17:31:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPVRM1Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989029
Page 114 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020 15:41Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2f84\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-2021-5683-0989030
Page 115 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Nov-13-2020 17:59:45
(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
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-13-2020 17:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989031
Page 116 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020 15:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989032
Page 117 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-16-2020 15:05:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-16-2020 15:05:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-16-2020 15:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-16-2020 15:05:33
(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.
Dec-16-2020 15:05:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
5.a
Date Location User Value Reason
Dec-16-2020 15:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS5HMHInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989033
Page 118 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-16-2020 15:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS5HMHInitial Entry
5.b
Date Location User Value Reason
Dec-16-2020 15:59:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS5HMKInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-16-2020 15:59:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS5HMKInitial Entry
5.c
Date Location User Value Reason
Dec-16-2020 15:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS5HMJInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-16-2020 15:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS5HMJInitial Entry
5.d
Date Location User Value Reason
Dec-16-2020 16:00:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVRRXInitial Entry
090177e196ae2f84\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989034
Page 119 of 143
***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, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Dec-16-2020 16:00:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPVRRXInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989035
Page 120 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989036
Page 121 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0989037
Page 122 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
00:23:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Re
issued:Cand
idatePending SDB
update
Mar-11-2021
10:03:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: An
sweredClinician has
submitted
documents
reporting this to
safety database
Mar-08-2021
22:53:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Op
enedSAE RECON:
Exposure During
Pregnancy(Onset
date:01Oct2020)
is not reported to
Safety database
but recorded on
AE CRF. Please
confirm and
report to Pfizer
immediately
Feb-26-2021
15:48:38
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 4: Cl
osedDiscrepancy has
been closed.
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989038
Page 123 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time
(US & Canada)
Feb-26-2021
12:30:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: An
sweredTranscription
Error
Feb-26-2021
12:30:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Drug Expos
ure During
PregnancyTranscription
Error
Feb-26-2021
11:25:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Re
issued:Open
edCoding: Per
coding please
update to Drug
exposure during
pregnancy. Thank
you
Feb-23-2021
17:04:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: An
sweredPer previous
query, name of
adverse event was
changed from
Pregnancy to
Exposure to
Pregnancy.
Pregnancy was
requested to be
added as an AE,
as the participant
had medication
abortion between
vax 1 and 2.
Feb-21-2021
12:17:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 4: Op
enedClarify
EXPOSURE TO
PREGNANCY as
follows...The
term is unclear.
Are you reporting
EXPOSURE
DURING
PREGNANCY?
If so, update the
verbatim term as
such. Otherwise
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989039
Page 124 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
clarify and update
the term as
appropriate.
Thank you.
Feb-21-2021
12:09:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 3: Cl
osedDiscrepancy has
been closed.
Feb-21-2021
05:55:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 3: Op
enedClarify
EXPOSURE TO
PREGNANCY as
follows...The
term appears
incomplete. Are
you reporting
EXPOSURE
DURING
PRENANCY?
MATERNAL
VACCINE
EXPOSURE?
Other? Please
update the
verbatim term to
clarify. Thank
you.
Feb-21-2021
04:04:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 2: Cl
osedDiscrepancy has
been closed.
Feb-19-2021
14:14:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies
query
Feb-19-2021
11:19:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredOriginal AE
reported as
pregnancy. Per
query, AE term
changed to
Exposure to
pregnancy. This
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989040
Page 125 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
AE is added per
query to report
pregnancy that
was terminated
before
vaccination 2.
Feb-19-2021
10:32:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 2: Op
enedClarify
EXPOSURE TO
PREGNANCY as
follows...The
term appears
incomplete. Are
you reporting
EXPOSURE
DURING
PRENANCY?
MATERNAL
VACCINE
EXPOSURE?
Other? Please
update the
verbatim term to
clarify. Thank
you.
Feb-19-2021
08:34:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredTranscription
Error
Feb-19-2021
08:34:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Exposure to
PregnancyTranscription
Error
Feb-18-2021
16:53:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Op
enedCLINQUERY:
Pregnancy is not
an AE- Exposure
to pregnancy
would be the
appropriate term.
Feb-18-2021
13:06:51
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data Entry
:
PregnancyInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0989041
Page 126 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(US & Canada)
4. Start Date Time:
Date Location User Value Reason
Mar-01-2021 10:03:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-26-2021 12:31:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Pregnancy
requested to be
added as an AE. Per
sonogram,
pregnancy actually
started before
informed consent
date. False negative
pregnancy test
made her eligible
for vax 1
Feb-26-2021 12:30:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened For Drug Exposure
During Pregnancy:
Start date
01/Oct/2020 is
before V1D1VX1L
visit date 21/Oct
/2020. Please
review and update
as appropriate.
Feb-24-2021 10:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened DM: Per protocol,
AEs are collected
after informed
consent date, Please
review and correct.
Feb-23-2021 17:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Pregnancy
requested to be
added as an AE. Per
sonogram,
pregnancy actually
started before
informed consent
date. False negative
pregnancy test
made her eligible
for vax 1.
090177e196ae2f84\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-2021-5683-0989042
Page 127 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-19-2021 18:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-19-2021 18:20:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened DM RQ: Per
protocol, AEs are
collected after
informed consent.
The start date is
prior to informed
consent; therefore,
please review and
update
appropriately.
Feb-19-2021 08:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Per sonogram done
on 11/9/2020,
doctor confirmed
she was 5 weeks 4
days pregnant. On
visit day 1 Oct 21, a
pregnancy test was
negative. This was a
false negative.
Feb-19-2021 08:34:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened For Exposure to
Pregnancy: Start
date 01/Oct/2020 is
before V1D1VX1L
visit date 21/Oct
/2020. Please
review and update
as appropriate.
Feb-19-2021 00:23:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-18-2021 13:10:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per query response,
pregnancy is
reported as AE.
Pregnancy was
confirmed to start
Oct 1 by sonogram
on 11/9/20 when
medication abortion
was administered.
Oct 21 pregnancy
test on vax 1 visit
090177e196ae2f84\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-2021-5683-0989043
Page 128 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
was false negative.
Feb-18-2021 13:09:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered False negative
pregnancy test on
Oct 21 is reason for
vaccination during
pregnancy.
Participant had
medication abortion
to terminate
pregnancy on
11/9/20, and
confirmed by
sonogram on
11/13/20.
Feb-18-2021 13:07:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For Pregnancy:
Start date
01/Oct/2020 is
before V1D1VX1L
visit date 21/Oct
/2020. Please
review and update
as appropriate.
Feb-18-2021 13:07:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKTranscription Error
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For Pregnancy:
Start date
10/Oct/2020 is
before V1D1VX1L
visit date 21/Oct
/2020. Please
review and update
as appropriate.
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start date is before
Consent Date
21/Oct/2020.
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae2f84\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-2021-5683-0989044
Page 129 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae2f84\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-2021-5683-0989045
Page 130 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Pregnancy
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021 13:06:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f84\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-2021-5683-0989046
Page 131 of 143
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Medication abortionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f84\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-2021-5683-0989047
Page 132 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0989048
Page 133 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021 22:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0989049
Page 134 of 143
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Mar-11-2021 12:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0989050
Page 135 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Mar-11-2021 12:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Mar-11-2021 12:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Mar-11-2021 12:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Mar-11-2021 12:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Moderna COVID-19 VaccineTranscription Error
Mar-11-2021 12:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Moderna VaccineInitial Entry
5. Date:
Date Location User Value Reason
Mar-11-2021 12:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae2f84\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-2021-5683-0989051
Page 136 of 143
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
Dec-16-2020 15:05:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-16-2020 15:05:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-16-2020 15:05:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989052
Page 137 of 143
***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: 12041280 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-26-2021 17:58:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-25-2021 18:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-25-2021 18:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/6/2021New Information
Feb-25-2021 09:31:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please verify if the
date of subject
confirmation to
unblinded was on
06Jan2021. Update
CRF as needed.
Feb-20-2021 19:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/5/2021Transcription Error
Feb-18-2021 22:33:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/6/2021Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0989053
Page 138 of 143
***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, Answered Queries
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 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
Mar-11-2021 18:10:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to r
eturn for Vaccination 3 OR oth
erwise not eligibleplease see previous
audit trail; pt
received Moderna
vaccine outside of
trial so 'not willing
to return or
otherwise not
eligible" is more
appropriate
Mar-11-2021 18:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Transcription Error
Mar-11-2021 11:58:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Mar-11-2021 11:58:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to r
eturn for Vaccination 3 OR oth
erwise not eligibleTranscription Error
Mar-11-2021 09:35:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Please confirm if
this should be
changed to not
eligible/willing
since subject
received Moderna
vaccine outside of
study. Update CRFs
as needed.
Feb-18-2021 22:35:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae2f84\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-2021-5683-0989054
Page 139 of 143
***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, Answered Queries
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai
Subject No: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-18-2021 22:34:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-18-2021 22:34:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per other protocol a
llowance(s) and confirmed
to have received only place
bo at Vaccination 1/2Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989055
Page 140 of 143
***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: 12041280 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 22:35:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-12-2021
03:21:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedQuery closed based on
site response.
Mar-11-2021
18:14:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dIt appears the pt was
thought to be eligible
when they were
contacted re:
unblinding, which is
why eligibility was
assessed, but then the
pt disclosed they had
received the Moderna
vax so they were no
longer eligible. data
correct as entered.
Mar-11-2021
16:47:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7679248;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0989056
Page 141 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-18-2021
22:35:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0989057
Page 142 of 143
***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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-16-2020 15:05:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-21-2020 17:59:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-21-2020 16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-16-2020 15:05:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/16/2020Initial Entry
Oct-21-2020 17:59:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Oct-21-2020 16:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0989058
Page 143 of 143
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12041280 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 11:00:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f84\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0989059