125742 S1 M5 CRF c4591001 1140 11401282

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
152
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 152
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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 version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985710
Page 2 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
Oct/13/2020
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985711
Page 3 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11401282]
2.Birth Date: /1984
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0985712
Page 4 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985713
Page 5 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985714
Page 6 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985715
Page 7 of 152
***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: 11401282 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:[MIGRAINES]
Start Date: UNK/UNK/1985
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RECONSTRUCTIVE SURGERIES]
Start Date: Nov/11/2016
Ongoing: NO
End Date:
Jun/24/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Motor Vehicle Accident]
Start Date: Nov/11/2016
Ongoing: NO
End Date:
Nov/11/2016
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985716
Page 8 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985717
Page 9 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
2.Weight: [211.2]
3.Unit: LB
4.Height: [69.2]
5.Unit: in
6.Body Mass Index: [31.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985718
Page 10 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/13/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985719
Page 11 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/13/2020
2.Randomization Number: [107214]
3.Randomization Group: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985720
Page 12 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYZCC]
5.bSample ID [BPG5X3]
5.cSample ID [BPG5X2]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985721
Page 13 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYZCB]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985722
Page 14 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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: Oct/13/2020 15:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985723
Page 15 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985724
Page 16 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985725
Page 17 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985726
Page 18 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/3/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985727
Page 19 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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:
Nov/3/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8DGK]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985728
Page 20 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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: Nov/3/2020 12:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985729
Page 21 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/1/2020
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985730
Page 22 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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:
Dec/1/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8DKV]
5.bSample ID [BLGBPY]
5.cSample ID [BLGBPZ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985731
Page 23 of 152
***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: 11401282 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:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985732
Page 24 of 152
***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: 11401282 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: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985733
Page 25 of 152
***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: 11401282 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 [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985734
Page 26 of 152
***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: 11401282 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 [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985735
Page 27 of 152
***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: 11401282 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?
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985736
Page 28 of 152
***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: 11401282 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:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985737
Page 29 of 152
***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: 11401282 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:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985738
Page 30 of 152
***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: 11401282 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 [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985739
Page 31 of 152
***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: 11401282 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:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985740
Page 32 of 152
***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: 11401282 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 [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985741
Page 33 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Exercise induced
Asthma Nov/UNK/2020 U
NK:UNK YES  Repeating
Pages
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985742
Page 34 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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)[Exercise induced Asthma]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985743
Page 35 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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:
[Exercise Induced]
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?: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[ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985744
Page 36 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985745
Page 37 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985746
Page 38 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985747
Page 39 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985748
Page 40 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985749
Page 41 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985750
Page 42 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985751
Page 43 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985752
Page 44 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985753
Page 45 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985754
Page 46 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985755
Page 47 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985756
Page 48 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985757
Page 49 of 152
***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: 11401282 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:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985758
Page 50 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985759
Page 51 of 152
***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: 11401282 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?
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985760
Page 52 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985761
Page 53 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985762
Page 54 of 152
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985763
Page 55 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985764
Page 56 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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 other protocol allowance(s) and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985765
Page 57 of 152
***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: 11401282 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: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985766
Page 58 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985767
Page 59 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985768
Page 60 of 152
***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: 11401282 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: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985769
Page 61 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985770
Page 62 of 152
***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: 11401282 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/15/2021
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985771
Page 63 of 152
***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: 11401282 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
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985772
Page 64 of 152
***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: 11401282 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/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985773
Page 65 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/15/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985774
Page 66 of 152
***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: 11401282 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:
Jan/15/2021
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 [BP8DRW]
5.bSample ID [BNWXV6]
5.cSample ID [BNWXW3]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985775
Page 67 of 152
***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: 11401282 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/15/2021
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 [BP8DRT]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985776
Page 68 of 152
***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: 11401282 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/15/2021 12:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985777
Page 69 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985778
Page 70 of 152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/4/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985779
Page 71 of 152
***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: 11401282 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/4/2021
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 [BP8DWM]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985780
Page 72 of 152
***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: 11401282 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/4/2021 14:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985781
Page 73 of 152
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985782
Page 74 of 152
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985783
Page 75 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985784
Page 76 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985785
Page 77 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985786
Page 78 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985787
Page 79 of 152
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985788
Page 80 of 152
***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: 11401282 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 Dec/1/2020
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985789
Page 81 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Casebook Signature Form
1.Casebook Signature
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985790
Page 82 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985791
Page 83 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-14-2020 10:53:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985792
Page 84 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-15-2021 14:04:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985793
Page 85 of 152
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985794
Page 86 of 152
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
Oct-14-2020 10:51:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-14-2020 10:51:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30fd\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-2021-5683-0985795
Page 87 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020 10:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Oct/13/2020Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985796
Page 88 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020 10:50:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11401282Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020 10:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1984Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020 10:52:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-14-2020 10:52:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020 10:52:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30fd\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-2021-5683-0985797
Page 89 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 10:53:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985798
Page 90 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
Oct-14-2020 10:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 10:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020 10:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30fd\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-2021-5683-0985799
Page 91 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020 10:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:MIGRAINE
S
Start Date: UNK/UNK/
1985
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020 10:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 10:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MIGRAINESInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-14-2020 10:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1985Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985800
Page 92 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 10:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-19-2020 10:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:RECONSTRUC
TIVE SURGERI
ES
Start Date
:Nov/11/2016
Ongoing: NO
End Date:
Jun/24/2020Updated per
subject's
confirmation
Oct-19-2020 10:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:RECONSTRUC
TIVE SURGERI
ES
Start Date
:Oct/11/2016
Ongoing: NO
End Date:
Jun/24/2020Updated per query
Oct-14-2020 10:56:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:2Initial Entry
090177e196ae30fd\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-2021-5683-0985801
Page 93 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Medic
al Hist
ory Te
rm:RECONSTRUCTIV
E SURGERIES AFT
ER MOTOR VEHIC
LE ACCIDENT
Start
Date:Oct/11/2016
Ongoi
ng:NO
End Date:
Jun/24/2020
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985802
Page 94 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020 10:56:57
(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 ValueReason
Oct-19-2020
11:12:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Oct-19-2020
10:18:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dUpdated per query
Oct-19-2020
10:18:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
ONS
TRU
CTIV
E SU
RGE
RIESUpdated per query
Oct-15-2020
04:01:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedMultiple actions for
RECONSTRUCTIVE
SURGERIES AFTER
MOTOR VEHICLE
ACCIDENT: Split
the term into
RECONSTRUCTIVE
SURGERIES and
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0985803
Page 95 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
MOTOR VEHICLE
ACCIDENT and
report as two separate
entries and also
specify further
RECONSTRUCTIVE
SURGERIES. Are
you reporting LIMB
RECONSTRUCTIVE
SURGERY? FACE
RECONSTRUCTIVE
SURGERY? Other?
If multiple, please
report each as a
separate entry. Thank
you.
Oct-14-2020
10:56:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
ONS
TRU
CTIV
E SU
RGE
RIES
AFTE
R MO
TOR
VEHI
CLE
ACCI
DEN
TInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020 10:25:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2016Updated per
subject's
confirmation
090177e196ae30fd\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-2021-5683-0985804
Page 96 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 10:56:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/11/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020 10:56:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/24/2020Initial Entry
1.c
Date Location User Value Reason
Oct-19-2020 10:25:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Motor Vehicle
Accident
Start Date: Nov/11/2016
Ongoing: NO
End Date:
Nov/11/201
6updated per
subject's
confirmation
Oct-19-2020 10:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Motor Vehicle
Accident
Start Date: Nov/11/2016
Ongoing: NO
End Date:
Oct/11/201
6Updated per
subject's
confirmation
090177e196ae30fd\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-2021-5683-0985805
Page 97 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-19-2020 10:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Motor Vehicle
Accident
Start Date: Oct/11/2016
Ongoing: NO
End Date:
Oct/11/201
6Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985806
Page 98 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020 10:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 10:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Motor Vehicle AccidentInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020 10:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2016Updated per
subject's
confirmation
Oct-19-2020 10:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/11/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-19-2020 10:25:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-19-2020 10:25:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/11/2016updated per
subject's
confirmation
Oct-19-2020 10:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Term Motor
Vehicle Accident
End Date is prior
to Start Date.
090177e196ae30fd\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-2021-5683-0985807
Page 99 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-19-2020 10:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/11/2016Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985808
Page 100 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-14-2020 10:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985809
Page 101 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
211.2Initial Entry
3. Unit:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
69.2Initial Entry
5. Unit:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985810
Page 102 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.0Initial Entry
7.a
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 97.3
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985811
Page 103 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 10:58:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985812
Page 104 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985813
Page 105 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Oct-14-2020 10:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30fd\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-2021-5683-0985814
Page 106 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-14-2020 10:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-14-2020 10:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
107214Initial Entry
090177e196ae30fd\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-2021-5683-0985815
Page 107 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 10:59:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 10:59:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 10:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 10:59:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-14-2020 10:59:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985816
Page 108 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 10:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYZCCInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 10:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYZCCInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020 11:00:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG5X3Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020 11:00:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG5X3Initial Entry
5.c
Date Location User Value Reason
Oct-14-2020 11:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG5X2Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020 11:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG5X2Initial Entry
090177e196ae30fd\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-2021-5683-0985817
Page 109 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 11:01:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 11:01:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 11:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 11:01:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-14-2020 11:01:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985818
Page 110 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 11:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYZCBInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 11:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYZCBInitial Entry
090177e196ae30fd\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-2021-5683-0985819
Page 111 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020 15:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985820
Page 112 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020 11:02:21
(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
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-14-2020 11:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30fd\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-2021-5683-0985821
Page 113 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
Oct-14-2020 11:02:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985822
Page 114 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 13:58:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985823
Page 115 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-03-2020 13:58:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
2.a
Date Location User Value Reason
Nov-03-2020 13:58:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 98.0
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-03-2020 13:58:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-03-2020 13:58:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985824
Page 116 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-03-2020 13:58:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-03-2020 13:58:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30fd\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-2021-5683-0985825
Page 117 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985826
Page 118 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-03-2020 13:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30fd\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-2021-5683-0985827
Page 119 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 13:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 13:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 16:22:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 13:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-03-2020 13:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985828
Page 120 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-03-2020 16:22:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8DGKInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 16:22:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8DGKInitial Entry
090177e196ae30fd\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-2021-5683-0985829
Page 121 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020 12:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985830
Page 122 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-03-2020 13:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30fd\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-2021-5683-0985831
Page 123 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-01-2020 14:50:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/1/2020Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985832
Page 124 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-01-2020 14:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-01-2020 14:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-01-2020 16:39:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-01-2020 14:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-01-2020 14:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/1/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985833
Page 125 of 152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-01-2020 16:39:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8DKVInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-01-2020 16:39:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8DKVInitial Entry
5.b
Date Location User Value Reason
Dec-01-2020 16:40:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLGBPYInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-01-2020 16:40:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLGBPYInitial Entry
5.c
Date Location User Value Reason
Dec-01-2020 16:40:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLGBPZInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-01-2020 16:40:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLGBPZInitial Entry
090177e196ae30fd\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-2021-5683-0985834
Page 126 of 152
***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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985835
Page 127 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-04-2021 16:17:27
(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
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exercise induced AsthmaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985836
Page 128 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Exercise InducedInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae30fd\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-2021-5683-0985837
Page 129 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-04-2021 16:17:27
(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
Feb-04-2021 16:17:27
(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
Feb-04-2021 16:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30fd\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-2021-5683-0985838
Page 130 of 152
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 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
Dec-01-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-01-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-01-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30fd\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-2021-5683-0985839
Page 131 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 16:17:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021Changed
Information
Jan-15-2021 14:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
090177e196ae30fd\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-2021-5683-0985840
Page 132 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-10-2021 16:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible per other protocol
allowance(s) and confirm
ed to have received only
placebo at Vaccination 1/
2Changed
Information
Jan-15-2021 14:06:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 14:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-15-2021 14:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible per local/national
recommendations and co
nfirmed to have received
only placebo at Vaccinati
on 1/2Initial Entry
090177e196ae30fd\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-2021-5683-0985841
Page 133 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-15-2021 14:06:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-15-2021 14:06:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae30fd\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-2021-5683-0985842
Page 134 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-15-2021 14:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985843
Page 135 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-15-2021 14:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Jan/15/2021Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985844
Page 136 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
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: 11401282 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
Jan-15-2021 14:05:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-15-2021 14:05:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-15-2021 14:05:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30fd\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-2021-5683-0985845
Page 137 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985846
Page 138 of 152
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Jan-15-2021 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30fd\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-2021-5683-0985847
Page 139 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-15-2021 14:05:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 14:05:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-15-2021 16:08:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 14:05:32
(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.
Jan-15-2021 14:05:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/15/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985848
Page 140 of 152
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-15-2021 16:08:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8DRWInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-15-2021 16:08:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8DRWInitial Entry
5.b
Date Location User Value Reason
Jan-15-2021 16:08:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWXV6Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-15-2021 16:08:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWXV6Initial Entry
5.c
Date Location User Value Reason
Jan-15-2021 16:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWXW3Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-15-2021 16:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWXW3Initial Entry
090177e196ae30fd\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-2021-5683-0985849
Page 141 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-15-2021 14:05:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 14:05:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-15-2021 16:09:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 14:05:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-15-2021 14:05:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/15/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985850
Page 142 of 152
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-15-2021 16:09:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8DRTInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-15-2021 16:09:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8DRTInitial Entry
090177e196ae30fd\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-2021-5683-0985851
Page 143 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 11401282 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
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021 12:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985852
Page 144 of 152
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-15-2021 14:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30fd\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-2021-5683-0985853
Page 145 of 152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 16:00:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985854
Page 146 of 152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0985855
Page 147 of 152
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Feb-04-2021 16:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30fd\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-2021-5683-0985856
Page 148 of 152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 16:00:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 16:00:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021 11:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-04-2021 23:00:34
(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.
Feb-04-2021 16:00:46
(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.
Feb-04-2021 16:00:46
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30fd\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-2021-5683-0985857
Page 149 of 152
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Date of Collection:
Feb/4/2021
5.a
Date Location User Value Reason
Feb-05-2021 11:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8DWMInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-05-2021 11:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8DWMInitial Entry
090177e196ae30fd\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-2021-5683-0985858
Page 150 of 152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 11401282 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
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021 14:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30fd\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-2021-5683-0985859
Page 151 of 152
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-04-2021 16:19:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30fd\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-2021-5683-0985860
Page 152 of 152
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401282 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-01-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-14-2020 10:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-14-2020 10:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-01-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/1/2020Initial Entry
Oct-14-2020 10:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Oct-14-2020 10:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
090177e196ae30fd\Final\Final On: 01-Apr-2021 04:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0985861
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