125742 S1 M5 CRF c4591001 1204 12041234

Document text

Page 1 of 210
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988707
Page 2 of 210
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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/14/2020
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988708
Page 3 of 210
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12041234]
2.Birth Date: 1982
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988709
Page 4 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988710
Page 5 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988711
Page 6 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988712
Page 7 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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:[Spondylolysis]
Start Date: Jan/1/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tonsillectomy]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988713
Page 8 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Strep Throat]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988714
Page 9 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988715
Page 10 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
2.Weight: [199.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [27.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988716
Page 11 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/14/2020
2.Randomization Number: [107705]
3.Randomization Group: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988717
Page 12 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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/14/2020
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 [BPYN7S]
5.bSample ID [BNWLMH]
5.cSample ID [BNWLMK]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988718
Page 13 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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/14/2020
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 [BPYN78]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988719
Page 14 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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/14/2020 16:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988720
Page 15 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988721
Page 16 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988722
Page 17 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988723
Page 18 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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/4/2020
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 [BRBZY1]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988724
Page 19 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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/4/2020 12:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988725
Page 20 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988726
Page 21 of 210
***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: 12041234 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/3/2020
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 [BS5HDL]
5.bSample ID [BS5HDN]
5.cSample ID [BS5HDM]
5.dSample ID [BPVRYZ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988727
Page 22 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988728
Page 23 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988729
Page 24 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988730
Page 25 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988731
Page 26 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988732
Page 27 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988733
Page 28 of 210
***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: 12041234 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:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988734
Page 29 of 210
***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: 12041234 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: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988735
Page 30 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988736
Page 31 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988737
Page 32 of 210
***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: 12041234 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?
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988738
Page 33 of 210
***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: 12041234 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:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988739
Page 34 of 210
***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: 12041234 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:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988740
Page 35 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988741
Page 36 of 210
***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: 12041234 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:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988742
Page 37 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988743
Page 38 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  Muscle tenderness at
injection site Oct/15/20
20 08:00 NO
End Date Time:
Oct/18/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERS
E EVENT 2  Swollen, tender left
axillary lymph node Oct/17/20
20 05:00 NO
End Date Time:
Oct/22/2020 10:
00
 Repeating
Pages
 3.ADVERS
E EVENT 3  Fatigue  Oct/15/20
20 05:00 NO
End Date Time:
Oct/15/2020 14:
00
 Repeating
Pages
 4.ADVERS
E EVENT 4  Muscle tenderness at
injection site Nov/4/20
20 14:00 NO
End Date Time:
Nov/6/2020 18:0
0
 Repeating
Pages
 5.ADVERS
E EVENT 5  Low grade fever, 10
0.7 Nov/5/20
20 02:00 NO
End Date Time:Repeating
Pages
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988744
Page 39 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
Nov/6/2020 11:0
0
 
 6.ADVERS
E EVENT 6  Chills  Nov/5/20
20 02:00 NO
End Date Time:
Nov/6/2020 18:0
0
 Repeating
Pages
 7.ADVERS
E EVENT 7  Headache  Nov/5/20
20 02:00 NO
End Date Time:
Nov/6/2020 18:0
0
 Repeating
Pages
 8.ADVERS
E EVENT 8  Right axillary lymph
node swelling Nov/5/20
20 12:00 NO
End Date Time:
Nov/11/2020 UN
K:UNK
 Repeating
Pages
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988745
Page 40 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Muscle tenderness at injection site]
4.Start Date Time: Oct/15/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/18/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988746
Page 41 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988747
Page 42 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988748
Page 43 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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)[Swollen, tender left axillary lymph node]
4.Start Date Time: Oct/17/2020 05:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/22/2020 10:00
6.Toxicity Grade: 1
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988749
Page 44 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988750
Page 45 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988751
Page 46 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fatigue]
4.Start Date Time: Oct/15/2020 05:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/15/2020 14:00
6.Toxicity Grade: 1
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988752
Page 47 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988753
Page 48 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988754
Page 49 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Muscle tenderness at injection site]
4.Start Date Time: Nov/4/2020 14:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 18:00
6.Toxicity Grade: 1
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988755
Page 50 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988756
Page 51 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988757
Page 52 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Low grade fever, 100.7]
4.Start Date Time: Nov/5/2020 02:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 11:00
6.Toxicity Grade: 1
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988758
Page 53 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988759
Page 54 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988760
Page 55 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Chills]
4.Start Date Time: Nov/5/2020 02:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 18:00
6.Toxicity Grade: 1
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988761
Page 56 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988762
Page 57 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988763
Page 58 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Headache]
4.Start Date Time: Nov/5/2020 02:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 18:00
6.Toxicity Grade: 2
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988764
Page 59 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988765
Page 60 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988766
Page 61 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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: [8]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Right axillary lymph node swelling]
4.Start Date Time: Nov/5/2020 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/11/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988767
Page 62 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988768
Page 63 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988769
Page 64 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988770
Page 65 of 210
***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: 12041234 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[ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988771
Page 66 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Influenza V
accine Nov/25
/2020 Repeating
Pages
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988772
Page 67 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Influenza Vaccine]
5.Date: Nov/25/2020
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988773
Page 68 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988774
Page 69 of 210
***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: 12041234 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?
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988775
Page 70 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988776
Page 71 of 210
***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: 12041234 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?
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988777
Page 72 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988778
Page 73 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988779
Page 74 of 210
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988780
Page 75 of 210
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988781
Page 76 of 210
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988782
Page 77 of 210
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988783
Page 78 of 210
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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?
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988784
Page 79 of 210
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988785
Page 80 of 210
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988786
Page 81 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988787
Page 82 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988788
Page 83 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988789
Page 84 of 210
***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: 12041234 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 [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988790
Page 85 of 210
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988791
Page 86 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988792
Page 87 of 210
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988793
Page 88 of 210
***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: 12041234 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: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988794
Page 89 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/7/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988795
Page 90 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988796
Page 91 of 210
***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: 12041234 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: [ ]
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988797
Page 92 of 210
***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: 12041234 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/3/2020
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988798
Page 93 of 210
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988799
Page 94 of 210
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988800
Page 95 of 210
***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, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-14-2020 16:24:48 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988801
Page 96 of 210
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-24-2021 20:24:45 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Judith
Aberg Approved Jan-25-2021 16:24:35 (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.
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988802
Page 97 of 210
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Nov-23-2020 11:19:57 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-11-2020 15:33:26 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988803
Page 98 of 210
***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, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-14-2020
16:23:55
(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-14-2020
16:23:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988804
Page 99 of 210
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020
16:24:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Oct/14/2020Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988805
Page 100 of 210
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020
16:23:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12041234Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020
16:23:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1982Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020
16:24:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988806
Page 101 of 210
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
16:24:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020
16:24:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988807
Page 102 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-14-2020
16:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988808
Page 103 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-14-2020
16:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
16:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
16:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988809
Page 104 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020
16:27:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Spondy
lolysis
Start Date: Jan/1/2
017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020
16:27:15
(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-14-2020
16:27:15
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
SpondylolysisInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988810
Page 105 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Oct-14-2020
16:27:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/1/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-14-2020
16:27:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-14-2020
16:27:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Tonsillecto
myInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988811
Page 106 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Start Date
:UNK/UN
K/1999
Ongoing: NO
End Date
:
UNK/U
NK/199
9
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988812
Page 107 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020
16:27:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
09:26:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Site confirmed
condition and
added to Med
History
Oct-16-2020
10:24:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dChanged data
per query
Oct-15-2020
14:00:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDClinical:
As per data
guidelines
conditions
which caused a
surgical
procedure
should be added
090177e196ae2f83\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-2021-5683-0988813
Page 108 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
as a separate
condition on
Medical
History. Please
add as a
separate
condition which
resulted in
Tonsillectomy.
Oct-14-2020
16:27:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
TonsillectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-14-2020
16:27:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020
16:27:54
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2f83\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-2021-5683-0988814
Page 109 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada) UNK/UNK/1999
1.c
Date Location User Value Reason
Oct-16-2020
10:23:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Strep Thro
at
Start Date
:UNK/UN
K/1999
Ongoing: NO
End Date
:
UNK/U
NK/199
9Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988815
Page 110 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Line/MH Number:
Date Location User Value Reason
Oct-16-2020
10:23:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020
10:23:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Strep ThroatInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-16-2020
10:23:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988816
Page 111 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-16-2020
10:23:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988817
Page 112 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-14-2020
16:28:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988818
Page 113 of 210
***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, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
199.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae2f83\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-2021-5683-0988819
Page 114 of 210
***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, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.8Initial Entry
7.a
Date Location User Value Reason
Oct-14-2020
16:28:30ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f83\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-2021-5683-0988820
Page 115 of 210
***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, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)Record Id
entifier::1
Temperat
ure:98.8
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.8Initial Entry
7.a Unit:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988821
Page 116 of 210
***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, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-14-2020
16:28:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988822
Page 117 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-14-2020
17:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-14-2020
17:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
107705Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988823
Page 118 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
16:29:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
16:29:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
09:51:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-15-2020 ACV0PFEINFP6000  Query 1: Opened 'Sample
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988824
Page 119 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
04:28:57
(UTC-05:00)
Eastern Time (US
& Canada)Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
16:29:07
(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-14-2020
16:29:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
09:51:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYN7SInitial Entry
090177e196ae2f83\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-2021-5683-0988825
Page 120 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
09:51:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYN7SInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020
09:51:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWLM
HInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
09:51:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWLMHInitial Entry
5.c
Date Location User Value Reason
090177e196ae2f83\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-2021-5683-0988826
Page 121 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-15-2020
09:51:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNWLM
KInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
09:51:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWLMKInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988827
Page 122 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
16:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
16:29:16
(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-15-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-15-2020 ACV0PFEINFP6000  Query 1: Opened 'Sample
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988828
Page 123 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
04:28:57
(UTC-05:00)
Eastern Time (US
& Canada)Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
16:29:16
(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-14-2020
16:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYN78Initial Entry
090177e196ae2f83\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-2021-5683-0988829
Page 124 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
09:51:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPYN78Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988830
Page 125 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-14-2020
17:13:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020
17:13:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020
17:13:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988831
Page 126 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-14-2020
17:13:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020 16:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020
17:13:17
(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-14-2020
17:13:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020
17:13:17
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988832
Page 127 of 210
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020
17:13:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-14-2020
17:13:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988833
Page 128 of 210
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-14-2020
17:13:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988834
Page 129 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-04-2020
12:18:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988835
Page 130 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-04-2020
12:19:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2.a
Date Location User Value Reason
Nov-04-2020
12:19:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:98.3
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-04-2020
12:19:12ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f83\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-2021-5683-0988836
Page 131 of 210
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Nov-04-2020
12:19:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-04-2020
12:19:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-04-2020
12:19:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f83\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-2021-5683-0988837
Page 132 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020
12:19:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020
12:19:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020
15:59:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-04-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988838
Page 133 of 210
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12:19:40
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-04-2020
12:19:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
Nov-04-2020
15:59:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRBZY
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-04-2020
15:59:12
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BRBZY1Initial Entry
090177e196ae2f83\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-2021-5683-0988839
Page 134 of 210
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988840
Page 135 of 210
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988841
Page 136 of 210
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020 12:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988842
Page 137 of 210
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-04-2020
14:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988843
Page 138 of 210
***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: 12041234 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-03-2020
13:54:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/3/2020Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988844
Page 139 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020
13:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020
13:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-03-2020
15:38:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-03-2020 ACV0PFEINFP6000  auto query Query 1: Candidate 'Sample
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988845
Page 140 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
13:55:25
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-03-2020
13:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
Dec-03-2020
15:38:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS5HD
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-03-2020
15:38:41
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
BS5HDLInitial Entry
090177e196ae2f83\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-2021-5683-0988846
Page 141 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
5.b
Date Location User Value Reason
Dec-03-2020
15:38:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS5HD
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-03-2020
15:38:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS5HDNInitial Entry
5.c
Date Location User Value Reason
Dec-03-2020
15:39:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS5HD
MInitial Entry
090177e196ae2f83\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-2021-5683-0988847
Page 142 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Sample ID
Date Location User Value Reason
Dec-03-2020
15:39:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS5HDMInitial Entry
5.d
Date Location User Value Reason
Dec-03-2020
15:39:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPVRY
ZInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-03-2020
15:39:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPVRYZInitial Entry
090177e196ae2f83\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-2021-5683-0988848
Page 143 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988849
Page 144 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988850
Page 145 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988851
Page 146 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988852
Page 147 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988853
Page 148 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988854
Page 149 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988855
Page 150 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988856
Page 151 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Muscle tenderness
at injection siteInitial Entry
4. Start Date Time:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988857
Page 152 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/18/2020 U
NK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2f83\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-2021-5683-0988858
Page 153 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae2f83\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-2021-5683-0988859
Page 154 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae2f83\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-2021-5683-0988860
Page 155 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-20-2020
16:53:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988861
Page 156 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Swollen, tender lef
t axillary lymph no
deInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988862
Page 157 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/17/2020 05:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020
18:47:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-23-2020
10:08:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edChanged
Information
Oct-23-2020
10:08:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/22/2020 1
0:00Changed
Information
Oct-22-2020 ACV0PFEINFP6000  Query 1: Opened Per source the
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988863
Page 158 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
21:47:52
(UTC-05:00)
Eastern Time
(US & Canada)end date is
22Oct2020
10:00 Please
confirm and
update EDC if
appropriate.
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196ae2f83\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-2021-5683-0988864
Page 159 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-20-2020
16:54:06ACV0PFEINFP6000  Data Entry:
NOT APPLICABInitial Entry
090177e196ae2f83\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-2021-5683-0988865
Page 160 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)LE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-23-2020
10:08:39
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
090177e196ae2f83\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-2021-5683-0988866
Page 161 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Canada)
Oct-23-2020
10:08:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDChanged Information
Oct-23-2020
10:08:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Swollen,
tender left axillary
lymph node: Response
to "What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-20-2020
16:54:06
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\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-2021-5683-0988867
Page 162 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988868
Page 163 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988869
Page 164 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020 05:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/15/2020 14
:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae2f83\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-2021-5683-0988870
Page 165 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae2f83\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-2021-5683-0988871
Page 166 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
& Canada)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2f83\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-2021-5683-0988872
Page 167 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-20-2020
16:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988873
Page 168 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Muscle tenderness
at injection siteInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988874
Page 169 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020 14:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020
16:42:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/6/2020 1
8:00Changed
Information
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f83\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-2021-5683-0988875
Page 170 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-05-2020
10:43:39
(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
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988876
Page 171 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020
10:43:39ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\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-2021-5683-0988877
Page 172 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-09-2020
16:42:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Nov-09-2020
16:42:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDChanged Information
Nov-09-2020
16:42:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Muscle
tenderness at injection
site: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Nov-05-2020
10:43:39ACV0PFEINFP6000  Data Entr
y:Initial Entry
090177e196ae2f83\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-2021-5683-0988878
Page 173 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time
(US &
Canada)RECOVE
RING/RE
SOLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020
10:43:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988879
Page 174 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Low grade fever, 1
00.7Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988880
Page 175 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020 02:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-23-2020
18:20:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Error
Dec-23-2020
18:19:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opene
dPlease verify
the stop time,
it does not
match the
source.
Dec-23-2020
18:18:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Dec-14-2020
10:39:03ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redTranscription
Error
090177e196ae2f83\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-2021-5683-0988881
Page 176 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time
(US & Canada)
Dec-14-2020
10:39:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time
:
Nov/6/2020 1
1:00Transcription
Error
Dec-13-2020
14:34:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dPlease verify
the stop date
and time,
update CRFs
as needed.
Nov-09-2020
16:43:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time
:
Nov/5/2020 0
2:00Changed
Information
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae2f83\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-2021-5683-0988882
Page 177 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-05-2020
11:14:18
(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
Nov-05-2020
11:14:18
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\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-2021-5683-0988883
Page 178 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f83\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-2021-5683-0988884
Page 179 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-09-2020
16:44:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Nov-09-2020
16:44:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDChanged Information
Nov-09-2020
16:43:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Low grade
fever, 100.7: Response
to "What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988885
Page 180 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
but AE End Date/Time
is present.
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RING/RE
SOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020
11:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988886
Page 181 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ChillsInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988887
Page 182 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020 02:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-23-2020
18:19:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Dec-14-2020
10:39:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redTranscription
Error
Dec-14-2020
10:39:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time
:
Nov/6/2020 1
8:00Transcription
Error
090177e196ae2f83\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-2021-5683-0988888
Page 183 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-13-2020
14:32:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dPlease verify
the stop date
and time,
update as
needed.
Nov-09-2020
16:43:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time
:
Nov/5/2020 0
2:00Changed
Information
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2f83\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-2021-5683-0988889
Page 184 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
Nov-05-2020
11:15:56
(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
Nov-05-2020
11:15:56
(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
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae2f83\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-2021-5683-0988890
Page 185 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae2f83\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-2021-5683-0988891
Page 186 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-09-2020
16:44:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Nov-09-2020
16:44:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDChanged Information
Nov-09-2020
16:43:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Chills:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RING/RE
SOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988892
Page 187 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-05-2020
11:15:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988893
Page 188 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988894
Page 189 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020 02:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020
16:45:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/6/2020 1
8:00Changed
Information
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae2f83\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-2021-5683-0988895
Page 190 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-05-2020
11:16:56
(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
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988896
Page 191 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020
11:16:56ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\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-2021-5683-0988897
Page 192 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-05:00)
Eastern Time (US
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-09-2020
17:05:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
Nov-09-2020
17:05:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDChanged Information
Nov-09-2020
16:45:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Headache:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data Entr
y:
RECOVE
RING/REInitial Entry
090177e196ae2f83\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-2021-5683-0988898
Page 193 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(US &
Canada)SOLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020
11:16:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988899
Page 194 of 210
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Right axillary lym
ph node swellingInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988900
Page 195 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-27-2020
12:08:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response
satisfies query
Nov-23-2020
11:19:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edChanged
Information
Nov-23-2020
11:19:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/11/2020
UNK:UNKChanged
Information
Nov-23-2020 ACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0988901
Page 196 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
09:41:09
(UTC-05:00)
Eastern Time
(US & Canada)confirm if this
AE is still
ongoing
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-05-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0988902
Page 197 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)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.
Date Location User Value Reason
Nov-05-2020
14:44:21
(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
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOT APPLICAB
LEInitial Entry
090177e196ae2f83\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-2021-5683-0988903
Page 198 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Eastern Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-23-2020
11:20:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
losedClose Auto Query
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988904
Page 199 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-23-2020
11:20:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RED/RES
OLVEDChanged Information
Nov-23-2020
11:19:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: O
penedFor AE Right axillary
lymph node swelling:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
RECOVE
RING/RE
SOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-05-2020
14:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f83\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-2021-5683-0988905
Page 200 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-03-2020
13:55:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988906
Page 201 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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
Dec-03-2020
13:55:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Dec-03-2020
13:55:58
(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
Dec-03-2020
13:55:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988907
Page 202 of 210
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Provide the complete generic drug name (including salt form, where applicable). Where generic
name is unknown, enter the full trade or proprietary name. Include clarifying information in
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Dec-03-2020
13:55:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Influenza VaccineInitial Entry
5. Date:
Date Location User Value Reason
Dec-03-2020
13:55:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/25/2020Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988908
Page 203 of 210
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 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-03-2020
13:56:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-03-2020
13:56:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-03-2020
13:56:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988909
Page 204 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
07:54:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-24-2021
20:24:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edNew
Information
Feb-24-2021
20:24:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021New
Information
Feb-24-2021
17:49:32
(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.
090177e196ae2f83\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-2021-5683-0988910
Page 205 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-11-2021
15:06:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988911
Page 206 of 210
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-11-2021
15:07:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and NO
T confirmed to
have received o
nly placebo at
Vaccination 1/2Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988912
Page 207 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-11-2021
15:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-11-2021
15:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBI
LITY FOR ADDI
TIONAL VACCI
NATIONInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988913
Page 208 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-03-2020
13:56:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-14-2020
17:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-14-2020
16:25:05
(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-03-2020
13:56:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/3/2020Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988914
Page 209 of 210
***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: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-14-2020
17:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Oct-14-2020
16:25:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988915
Page 210 of 210
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount
Sinai
Subject No: 12041234 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
11:56:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Ena
bleInitial Entry
090177e196ae2f83\Final\Final On: 01-Apr-2021 03:45 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988916