Document text
Page 1 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984518
Page 2 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/7/2020
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984519
Page 3 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11401078]
2.Birth Date: /1947
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:
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984520
Page 4 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984521
Page 5 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984522
Page 6 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984523
Page 7 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diminished lung function due to lung surgery]
Start Date: Feb/1/2012
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[R upper lung lobectomy]
Start Date: Jan/11/2012
Ongoing: NO
End Date:
Jan/11/2012
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cardiac catheterization]
Start Date: Dec/7/2011
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: Dec/7/2011
Ongoing: YES
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984524
Page 8 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pre-diabetes]
Start Date: Apr/1/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: Apr/1/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: Oct/1/1965
Ongoing: NO
End Date:
Oct/1/1965
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lung cancer]
Start Date: Oct/1/2011
Ongoing: NO
End Date:
Feb/1/2012
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984525
Page 9 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gallbladder Attacks]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984526
Page 10 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [229.8]
3.Unit: LB
4.Height: [68.03]
5.Unit: in
6.Body Mass Index: [34.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984527
Page 11 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [224000]
3.Randomization Group: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984528
Page 12 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/7/2020
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 [BNB4BT]
5.bSample ID [BNB4BV]
5.cSample ID [BNB4BW]
5.dSample ID [BPG5CW]
5.eSample ID [BPG5CX]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984529
Page 13 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/7/2020
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 [BNB4BR]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984530
Page 14 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: Aug/7/2020 12:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984531
Page 15 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984532
Page 16 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984533
Page 17 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/17/2020
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984534
Page 18 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984535
Page 19 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984536
Page 20 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNB4KK]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984537
Page 21 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: Aug/28/2020 10:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984538
Page 22 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984539
Page 23 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984540
Page 24 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984541
Page 25 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BPYZ81]
5.bSample ID [BNWXMP]
5.cSample ID [BNWXMR]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984542
Page 26 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984543
Page 27 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984544
Page 28 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984545
Page 29 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984546
Page 30 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984547
Page 31 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984548
Page 32 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984549
Page 33 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984550
Page 34 of 230
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984551
Page 35 of 230
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984552
Page 36 of 230
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Sep/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984553
Page 37 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984554
Page 38 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984555
Page 39 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984556
Page 40 of 230
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# CategoryAE Ident
ifierAdverse Eve
ntStart DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1. ADVERSE E
VENT 1 Acute Cholec
ystitis Sep/16/2020 08:0
0 NO
End Date Time:
Sep/30/2020 UNK:UN
K
Repeating
Pages
2. DELETED ADVERSE E
VENT 2 Acute Cholec
ystitis Sep/16/2020 UN
K:UNK YES Repeating
Pages
3. ADVERSE E
VENT 3 Diarrhea Aug/19/2020 UN
K:UNK NO
End Date Time:
Aug/31/2020 UNK:UN
K
Repeating
Pages
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984557
Page 41 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Acute Cholecystitis]
4.Start Date Time: Sep/16/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/30/2020 UNK:UNK
6.Toxicity Grade: 3
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984558
Page 42 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Subject with history of gallstones and associated gallbladder wall
thickening]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[2020363638]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984559
Page 43 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Acute Cholecystitis ]
4.Start Date Time: Sep/16/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[History of gallbladder attacks ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984560
Page 44 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984561
Page 45 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Diarrhea]
4.Start Date Time: Aug/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Directly related to subject's acute cholecystitis]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984562
Page 46 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984563
Page 47 of 230
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984564
Page 48 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error
associated with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number:
For Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984565
Page 49 of 230
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984566
Page 50 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984567
Page 51 of 230
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applica
ble Repeating
Pages
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984568
Page 52 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984569
Page 53 of 230
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
1.Not Applicab
le Not Applicable Not Applicable Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984570
Page 54 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984571
Page 55 of 230
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984572
Page 56 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984573
Page 57 of 230
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984574
Page 58 of 230
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984575
Page 59 of 230
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984576
Page 60 of 230
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984577
Page 61 of 230
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984578
Page 62 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984579
Page 63 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984580
Page 64 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984581
Page 65 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/13/2021
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984582
Page 66 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984583
Page 67 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Jan/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984584
Page 68 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Nurse was unable to draw blood after 3 attempts]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984585
Page 69 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6JHP]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984586
Page 70 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 09:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984587
Page 71 of 230
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/7/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984588
Page 72 of 230
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984589
Page 73 of 230
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984590
Page 74 of 230
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984591
Page 75 of 230
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/3/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8DW6]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984592
Page 76 of 230
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/3/2021 10:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984593
Page 77 of 230
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984594
Page 78 of 230
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/4/2021
3.Comments: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984595
Page 79 of 230
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984596
Page 80 of 230
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984597
Page 81 of 230
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984598
Page 82 of 230
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984599
Page 83 of 230
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Mar/4/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984600
Page 84 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/25/2020
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984601
Page 85 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984602
Page 86 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen
Thomas Approved Mar-11-2021 20:29:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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.
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984603
Page 87 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-07-2020 15:22:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984604
Page 88 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-21-2020 16:13:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984605
Page 89 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-21-2020 16:13:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984606
Page 90 of 230
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2Sep-21-2020 16:13:59 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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3Sep-21-2020 16:13:59 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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4Sep-21-2020 16:13:59 (UTC-05:00) Eastern
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5Sep-21-2020 16:13:59 (UTC-05:00) Eastern
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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6Sep-21-2020 16:13:59 (UTC-05:00) Eastern
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
7Sep-21-2020 16:13:59 (UTC-05:00) Eastern
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(b) (4), (b) (6)
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Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
8Sep-21-2020 16:13:59 (UTC-05:00) Eastern
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Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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9Sep-21-2020 16:13:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
10Sep-21-2020 16:13:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4), (b) (6)
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Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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FormSep-21-2020 16:14:09 (UTC-05:00) Eastern
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(b) (4), (b) (6)
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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1Sep-21-2020 16:14:09 (UTC-05:00) Eastern
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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2Sep-21-2020 16:14:09 (UTC-05:00) Eastern
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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3Sep-21-2020 16:14:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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4Sep-21-2020 16:14:09 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5Sep-21-2020 16:14:09 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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1Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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2Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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3Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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4Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
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Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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5Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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6Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
7Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
8Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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9Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
10Sep-21-2020 16:14:19 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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FormSep-21-2020 16:14:31 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
1Sep-21-2020 16:14:31 (UTC-05:00) Eastern
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
2Sep-21-2020 16:14:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
3Sep-21-2020 16:14:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
4Sep-21-2020 16:14:31 (UTC-05:00) Eastern
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5Sep-21-2020 16:14:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
6Sep-21-2020 16:14:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984639
Page 123 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-21-2020 16:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984640
Page 124 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-21-2020 16:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984641
Page 125 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-21-2020 16:14:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984642
Page 126 of 230
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-13-2021 11:32:07 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984643
Page 127 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen
Thomas Approved Mar-11-2021 20:29:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-03-2021 11:27:27 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Jan-25-2021 20:15:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-13-2021 11:30:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984644
Page 128 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Stephen
Thomas Approved Jan-08-2021 10:21:46 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-23-2020 15:33:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Oct-12-2020 09:54:07 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-25-2020 11:22:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Sep-24-2020 11:15:03 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984645
Page 129 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-24-2020 09:27:42 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Sep-22-2020 15:05:01 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-21-2020 16:13:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Sep-17-2020 20:38:15 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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.
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984646
Page 130 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-07-2020 15:21:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-07-2020 15:21:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984647
Page 131 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020 15:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/7/2020Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984648
Page 132 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-07-2020 15:21:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11401078Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-07-2020 15:21:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-07-2020 15:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-07-2020 15:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-07-2020 15:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984649
Page 133 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-07-2020 15:22:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984650
Page 134 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-07-2020 15:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-07-2020 15:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-07-2020 15:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984651
Page 135 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-07-2020 15:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term:diminished lung funct
ion due to lung surger
y
Start Date: Feb/1/2012
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:23:12
(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
Aug-07-2020 15:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
diminished lung function due to lu
ng surgeryInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-07-2020 15:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-07-2020 15:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984652
Page 136 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b
Date Location User Value Reason
Aug-07-2020 15:23:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical Histor
y Term:R upper lung lob
ectomy
Start Date: Jan/11/2012
Ongoing: NO
End Date:
Jan/11/2012Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:23:51
(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
Aug-07-2020 15:23:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
R upper lung lobectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-07-2020 15:23:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2012Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-07-2020 15:23:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/11/2012Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984653
Page 137 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c
Date Location User Value Reason
Aug-07-2020 15:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:cardiac catheteri
zation
Start Date: Dec/7/2011
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:24:52
(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
Aug-07-2020 15:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cardiac catheterizationInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-07-2020 15:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2011Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-07-2020 15:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984654
Page 138 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-07-2020 15:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:hyperlipide
mia
Start Date: Dec/7/2011
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 15:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hyperlipidemiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-07-2020 15:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2011Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-07-2020 15:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-07-2020 15:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:pre-diabete
sInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984655
Page 139 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: Apr/1/2019
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 15:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pre-diabetesInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-07-2020 15:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/1/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-07-2020 15:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-07-2020 15:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:hypertensio
n
Start Date: Apr/1/2018
Ongoing: YESInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984656
Page 140 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 15:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-07-2020 15:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/1/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-07-2020 15:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-07-2020 15:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:appendectom
y
Start Date: Oct/1/1965
Ongoing: NO
End Date:
Oct/1/196
5Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984657
Page 141 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 15:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
appendectomyInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-07-2020 15:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/1965Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-07-2020 15:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/1/1965Initial Entry
1.h
Date Location User Value Reason
Aug-07-2020 15:30:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:lung cancer
Start Date: Oct/1/2011
Ongoing: NO
End Date:
Feb/1/20
12Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984658
Page 142 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-07-2020 15:30:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 15:30:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
lung cancerInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-07-2020 15:30:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2011Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-07-2020 15:30:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/1/2012Initial Entry
1.i
Date Location User Value Reason
Sep-17-2020 16:18:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Gallbladder Att
acks
Start Date: UNK/UNK/20
13
Ongoing: YESInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984659
Page 143 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-17-2020 16:18:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 16:18:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gallbladder AttacksInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-17-2020 16:18:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-17-2020 16:18:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984660
Page 144 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
229.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
68.03Initial Entry
5. Unit:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.9Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984661
Page 145 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7.a
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-07-2020 15:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984662
Page 146 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-10-2020 13:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-10-2020 13:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
224000Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984663
Page 147 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020 15:31:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020 15:31:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 13:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-07-2020 15:31:29
(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.
Aug-07-2020 15:31:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020 13:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4BTInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984664
Page 148 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 13:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4BTInitial Entry
5.b
Date Location User Value Reason
Aug-10-2020 13:28:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4BVInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020 13:28:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4BVInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020 13:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4BWInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-10-2020 13:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4BWInitial Entry
5.d
Date Location User Value Reason
Aug-10-2020 14:13:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5CWInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984665
Page 149 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Aug-10-2020 14:13:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5CWInitial Entry
5.e
Date Location User Value Reason
Aug-10-2020 14:14:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5CXInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020 14:14:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5CXInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984666
Page 150 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020 15:31:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020 15:31:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 13:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-07-2020 15:31:38
(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.
Aug-07-2020 15:31:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020 13:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4BRInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984667
Page 151 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 13:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4BRInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984668
Page 152 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020 12:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984669
Page 153 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-07-2020 15:32:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984670
Page 154 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-07-2020 15:32:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984671
Page 155 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 11:23:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984672
Page 156 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984673
Page 157 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984674
Page 158 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984675
Page 159 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020 09:52:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIARRH
EA
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:YES
Ongoing
?
NO
Stop
Date:
Au
g/1
7/2
020updated dates as per
subject's
confirmation
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984676
Page 160 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIAR
RHEA
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:YES
Ong
oing
?
YE
SInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984677
Page 161 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 08:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-02-2020 09:52:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered updated dates as per
subject's
confirmation
Sep-02-2020 09:52:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/17/2020updated dates as per
subject's
confirmation
Sep-01-2020 15:34:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary: Vaccination
2 is given for the
subject, however
DIARRHEA
associated with
Vaccination 1 is still
ongoing. Please
review and update
as appropriate. Else,
clarify in query
response. Thanks
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
YESInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984678
Page 162 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.g
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984679
Page 163 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984680
Page 164 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Injection Site Reaction: PAIN AInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984681
Page 165 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) : T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 11:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984682
Page 166 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 11:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2.a
Date Location User Value Reason
Aug-28-2020 11:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 11:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-28-2020 11:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-28-2020 11:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984683
Page 167 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-28-2020 11:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984684
Page 168 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 11:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 11:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 15:38:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 11:25:25
(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.
Aug-28-2020 11:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 15:38:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB4KKInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984685
Page 169 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 15:38:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4KKInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984686
Page 170 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 10:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984687
Page 171 of 230
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 15:55:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984688
Page 172 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 11:22:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984689
Page 173 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984690
Page 174 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984691
Page 175 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984692
Page 176 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984693
Page 177 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984694
Page 178 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984695
Page 179 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984696
Page 180 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 11:23:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984697
Page 181 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 11:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 11:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 09:35:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-26-2020 05:32:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-25-2020 11:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-25-2020 11:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984698
Page 182 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-28-2020 09:35:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYZ81Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 09:35:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYZ81Initial Entry
5.b
Date Location User Value Reason
Sep-28-2020 09:35:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWXMPInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020 09:35:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWXMPInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020 09:35:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWXMRInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-28-2020 09:35:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWXMRInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984699
Page 183 of 230
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-25-2020 12:58:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 12:58:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020 12:58:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984700
Page 184 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Sep-21-2020 16:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984701
Page 185 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-24-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Duplicate entry
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984702
Page 186 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Dec-23-2020 15:33:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984703
Page 187 of 230
***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, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-21-2020 16:13:48
(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-24-2020 19:33:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed THANK YOU.
Oct-22-2020 16:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered SAE FOLLOW/UP
REPORT UPDATED
Oct-22-2020 13:28:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened COVID testing has not been
recorded in the SAE
submitted to safety. If test
performed = YES, please
provide FU form with
results. If NOT test
performed or available,
please submit FU form as
well so it is reflected in the
narrative.
Oct-08-2020 02:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Oct-07-2020 14:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0984704
Page 188 of 230
***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, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-07-2020 14:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute CholecystitisChanged Information
Oct-02-2020 09:02:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020363638,
the term in AE CRF was
recorded as 'Cholecystitis'
while reported as 'Acute
cholecystitis' SDB. Please
confirm correct term. If
safety update is required,
please submit a follow-up
form.
Oct-01-2020 18:00:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Sep-30-2020 14:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-30-2020 14:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CholecystitisNew Information
Sep-28-2020 15:34:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Subject has a history of
gallbladder attacks. If the
recorded means he has had
Cholecystitis/cholelithiasis
in the past it will be relevant
to current SAE, please
update/revise accordingly.
Thank you.
Sep-24-2020 09:27:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute CholecystitisChanged as per safety unit
and monitor request
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Severe GI CrampingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-21-2020 16:13:48 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0984705
Page 189 of 230
***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, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern
Time (US & Canada)Sep/16/2020 08:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-09-2020 11:45:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/30/2020 UNK:UNKNew Information
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-10-2021 15:14:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-10-2021 12:30:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Mar-10-2021 12:30:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Transcription Error
Mar-10-2021 02:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: This
is usually not a life
threatening AE,
please clarify why
this is considered life
threatening.
Mar-09-2021 10:45:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY: This
is usually not a life
threatening AE,
please clarify why
this is considered life
threatening.
Sep-21-2020 16:13:48
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
4Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984706
Page 190 of 230
***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, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
Sep-22-2020 04:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Severe GI
Cramping:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984707
Page 191 of 230
***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, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
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
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Subject with history of galls
tones and associated gallbla
dder wall thickeningInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984708
Page 192 of 230
***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, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-21-2020 16:13:48
(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-13-2020
12:00:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Safety data updated
Oct-13-2020
10:19:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Ca
ndidateFor PSSR review
Oct-13-2020
09:09:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered Follow up form faxed today
13Oct2020.
Oct-12-2020
09:03:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020363638,outcome
was updated to
RECOVERED/RESOLVED on AE
CRF while retained as Not
Recovered/Not Resolved in Safety
database. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-09-2020
11:46:09
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0984709
Page 193 of 230
***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, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Canada)
Oct-09-2020
11:46:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDNew Information
Oct-09-2020
11:45:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Acute Cholecystitis :
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Sep-21-2020
16:13:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-21-2020 16:13:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-22-2020 04:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020363638Initial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0984710
Page 194 of 230
***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, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute CholecystitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984711
Page 195 of 230
***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, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
History of gallbladder attac
ksInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984712
Page 196 of 230
***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, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 12:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984713
Page 197 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-23-2020 15:33:56
(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
Jan-29-2021 13:52:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-29-2021 13:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-27-2021 10:12:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Capturing this on a
COVID illness CRF
will trigger a
Convalescent Visit
to be performed as
well. It does not
make sense to add a
COVID Illness Visit
for a symptom that
occurred in 8/2020
that has already
been determined to
be unrelated and is
resolved
Jan-27-2021 10:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Noted. However at
the time that this
occurred we had not
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0984714
Page 198 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
been provided with
clear guidance on
how to proceed.
Jan-25-2021 16:49:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Medical monitor:
Please the data
should still be
captured on the
appropriate CRF
pages (as for any
late data, we will
still capture it and
not ignore it) but a
swab will not be
required since the
symptoms have
resolved >4d
Jan-25-2021 16:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clin: Per Prot Sect
8.1., COVID-19
listed symptom
DIARRHEA should
have please
triggered a potential
COVID Illness Visit
irrespective of
perceived etiology
or clinical
significance. A nasal
swab will not be
collected and
captured on the
SOD form only
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DiarrheaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0984715
Page 199 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/31/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-23-2020 15:33:56
(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
Dec-23-2020 15:33:56
(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
Dec-23-2020 15:33:56
(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
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHERInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984716
Page 200 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
If Other, specify:
Directly related to subject's
acute cholecystitis
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-23-2020 15:33:56
(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
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-23-2020 15:33:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984717
Page 201 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984718
Page 202 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-21-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984719
Page 203 of 230
***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, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Sep-21-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Sep-21-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Sep-21-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Sep-21-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Sep-21-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d00\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
F
…[truncated]