125742 S1 M5 CRF c4591001 1013 10131656

Document text

Page 1 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138726
Page 2 of 175
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/7/2020
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138727
Page 3 of 175
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131656]
2.Birth Date: /1985
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0138728
Page 4 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138729
Page 5 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138730
Page 6 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138731
Page 7 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[TYPE 2 DIABETES MELLITUS]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[DIABETIC PERIPHERAL NEUROPATHY]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138732
Page 8 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138733
Page 9 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
2.Weight: [75.3]
3.Unit: kg
4.Height: [185.4]
5.Unit: cm
6.Body Mass Index: [21.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138734
Page 10 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/7/2020
2.Randomization Number: [104650]
3.Randomization Group: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138735
Page 11 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPC2L3]
5.bSample ID [BPC2L4]
5.cSample ID [BPC2L5]
5.dSample ID [BS6ZDL]
5.eSample ID [BSJT2M]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138736
Page 12 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRG2TZ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138737
Page 13 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/7/2020 11:16
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
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138738
Page 14 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138739
Page 15 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138740
Page 16 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138741
Page 17 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BR9TJJ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138742
Page 18 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/27/2020 10:56
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
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138743
Page 19 of 175
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138744
Page 20 of 175
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/24/2020
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 [BRHW1R]
5.bSample ID [BRHW1S]
5.cSample ID [BRHW1T]
5.dSample ID [BS0JGG]
5.eSample ID [BS0JGH]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138745
Page 21 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138746
Page 22 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138747
Page 23 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138748
Page 24 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138749
Page 25 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138750
Page 26 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138751
Page 27 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138752
Page 28 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138753
Page 29 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138754
Page 30 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138755
Page 31 of 175
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138756
Page 32 of 175
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
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FDA-CBER-2021-5683-0138757
Page 33 of 175
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  DIABETIC KE
TOACIDOSIS Jan/18/2021
UNK:UNK NO
End Date Time:
Jan/21/2021 UN
K:UNK
 Repeating
Pages
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138758
Page 34 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[DIABETIC KETOACIDOSIS]
4.Start Date Time: Jan/18/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 3
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Page 35 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[DIABETES]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
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Page 36 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021086899]
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Page 37 of 175
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138762
Page 38 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
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Page 39 of 175
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138764
Page 40 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: //
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Page 41 of 175
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138766
Page 42 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
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Page 43 of 175
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138768
Page 44 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138769
Page 45 of 175
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138770
Page 46 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138771
Page 47 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138772
Page 48 of 175
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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Page 49 of 175
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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FDA-CBER-2021-5683-0138774
Page 50 of 175
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
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Page 51 of 175
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
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Page 52 of 175
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138777
Page 53 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0138778
Page 54 of 175
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138779
Page 55 of 175
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138780
Page 56 of 175
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138781
Page 57 of 175
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138782
Page 58 of 175
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138783
Page 59 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138784
Page 60 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/12/2021
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138785
Page 61 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
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FDA-CBER-2021-5683-0138786
Page 62 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138787
Page 63 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BR9V6P]
5.bSample ID [BR9V6R]
5.cSample ID [BR9V6S]
5.dSample ID [BSLRWX]
5.eSample ID [BSLRWY]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138788
Page 64 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BR64CK]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138789
Page 65 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/12/2021 11:10
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
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138790
Page 66 of 175
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138791
Page 67 of 175
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR64L5]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138792
Page 68 of 175
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: Mar/3/2021 15:48
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
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138793
Page 69 of 175
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138794
Page 70 of 175
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138795
Page 71 of 175
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138796
Page 72 of 175
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138797
Page 73 of 175
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138798
Page 74 of 175
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138799
Page 75 of 175
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138800
Page 76 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/24/2020
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138801
Page 77 of 175
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138802
Page 78 of 175
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Mar-05-2021 21:01:05 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138803
Page 79 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-07-2020 14:09:20 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138804
Page 80 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-16-2021 08:18:47 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138805
Page 81 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Mar-05-2021 21:01:05 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Mar-04-2021 14:01:35 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Brown Approved Feb-25-2021 14:39:51 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138806
Page 82 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, PatriciaBrown, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Feb-15-2021 09:57:54 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-03-2021 12:07:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138807
Page 83 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Scott
Salmon N/A Feb-02-2021 12:49:33 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-02-2021 10:46:22 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Feb-01-2021 21:22:36 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-01-2021 09:55:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138808
Page 84 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Jan-28-2021 19:27:13 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Jan-21-2021 07:12:14 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138809
Page 85 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Scott
Salmon N/A Nov-24-2020 11:49:44 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Nov-10-2020 08:29:03 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138810
Page 86 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-07-2020
14:07:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-07-2020
14:07:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138811
Page 87 of 175
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-07-2020
14:07:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Oct/7/2020Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138812
Page 88 of 175
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-07-2020
14:07:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10131656Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-07-2020
14:07:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1985Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-07-2020
14:08:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0138813
Page 89 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:08:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-07-2020
14:08:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
WHITEInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138814
Page 90 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020
14:09:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/7/2020Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138815
Page 91 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-07-2020
14:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020
14:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020
14:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138816
Page 92 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Oct-08-2020
14:27:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Line/
MH N
umber
:1
Medic
al Hist
ory Te
rm:TYPE 2
DIABET
ES MEL
LITUS
Start
Date:UNK/U
NK/2016
Ongoi
ng:YESTranscription
Error
Oct-07-2020
14:11:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:1
Medic
al Hist
ory Te
rm:TYPE 2
DIABET
ES MEL
LITUS
Start
Date:UNK/U
NK/2016
Ongoi
ng:YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138817
Page 93 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.a Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:11:24
(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-09-2020
02:44:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response
satisfies query
Oct-08-2020
14:27:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Oct-08-2020
14:27:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
TYPE 2 DIABET
ES MELLITUSTranscription
Error
Oct-08-2020
14:21:40
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Swaranjali
Subhash Pawar
(pfe.pawars01)Query 1: Opened DM: A trailing
space is
identified. To
avoid
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138818
Page 94 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US & Canada) processing
errors, please
remove the
identified
character by
deleting the
entry and
re-entering the
data (without
using copy and
paste).
Oct-07-2020
14:11:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
TYPE 2 DIABET
ES MELLITUSInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-07-2020
14:11:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
UNK/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-07-2020
14:11:24
(UTC-05:00)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138819
Page 95 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)
1.b
Date Location User Value Reason
Oct-07-2020
14:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:2
Medica
l Histor
y Term:DIABETIC P
ERIPHERA
L NEUROPA
THY
Start D
ate:UNK/UNK/2
016
Ongoin
g:YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138820
Page 96 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020
14:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
DIABETIC PERIPH
ERAL NEUROPAT
HYInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-07-2020
14:12:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-07-2020
14:12:02ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138821
Page 97 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138822
Page 98 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-07-2020
14:12:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
The subject is NOT k
nown to be HIV POS
ITIVEInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138823
Page 99 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
75.3Initial Entry
3. Unit:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138824
Page 100 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
185.4Initial Entry
5. Unit:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.9Initial Entry
7.a
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.8Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138825
Page 101 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
CInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138826
Page 102 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Oct-07-2020
14:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138827
Page 103 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-07-2020
14:13:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-07-2020
14:13:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
104650Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138828
Page 104 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
14:13:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
14:13:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:05:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
14:13:57
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138829
Page 105 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-07-2020
14:13:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:05:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2L
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
16:05:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2L3Initial Entry
5.b
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138830
Page 106 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-07-2020
16:05:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2L
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020
16:05:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2L4Initial Entry
5.c
Date Location User Value Reason
Oct-07-2020
16:05:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2L
5Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138831
Page 107 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-07-2020
16:05:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2L5Initial Entry
5.d
Date Location User Value Reason
Oct-07-2020
16:06:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BS6ZD
LInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-07-2020
16:06:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BS6ZDLInitial Entry
5.e
Date Location User Value Reason
Oct-07-2020
16:06:07ACV0PFEINFP6000  Matthew
StephensData Entry:
Sample I BSJT2Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138832
Page 108 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: M
5.e Sample ID
Date Location User Value Reason
Oct-07-2020
16:06:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BSJT2MInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138833
Page 109 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
14:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
14:14:18
(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-07-2020
16:06:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
14:14:18
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138834
Page 110 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-07-2020
14:14:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:06:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRG2T
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
16:06:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRG2TZInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138835
Page 111 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138836
Page 112 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/7/2020 11:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138837
Page 113 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-07-2020
14:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138838
Page 114 of 175
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-07-2020
14:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138839
Page 115 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020
11:43:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/27/2020Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138840
Page 116 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-27-2020
11:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/27/2020Initial Entry
2.a
Date Location User Value Reason
Oct-27-2020
11:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:36.7
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-27-2020
11:43:50
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138841
Page 117 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-27-2020
11:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-27-2020
11:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-27-2020
11:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138842
Page 118 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020
11:44:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020
11:44:23
(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-27-2020
17:12:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-27-2020
11:44:23
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138843
Page 119 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-27-2020
11:44:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020
17:12:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR9TJ
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020
17:12:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BR9TJJInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138844
Page 120 of 175
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138845
Page 121 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/27/2020 10:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138846
Page 122 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-27-2020
11:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138847
Page 123 of 175
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-26-2020
00:52:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Usha Ogirala
(pfe.ogirau)Query 1: Closed Response
satisfies query
Nov-25-2020
08:11:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answered Original value
is correct
Nov-25-2020
05:00:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Amol Shinde
(pfe.shinda18)Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138848
Page 124 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
EOT to match
date of visit at
visit 3.
Nov-24-2020
11:49:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/24/2020Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138849
Page 125 of 175
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-24-2020
11:49:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020
11:49:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020
11:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-24-2020
11:49:58
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138850
Page 126 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-24-2020
11:49:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Nov/24/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020
11:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BRHW1
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020
11:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BRHW1RInitial Entry
5.b
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138851
Page 127 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Nov-24-2020
11:50:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BRHW1
SInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-24-2020
11:50:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BRHW1SInitial Entry
5.c
Date Location User Value Reason
Nov-24-2020
11:50:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BRHW1
TInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138852
Page 128 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Nov-24-2020
11:50:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BRHW1TInitial Entry
5.d
Date Location User Value Reason
Nov-24-2020
11:51:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BS0JG
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-24-2020
11:51:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BS0JGGInitial Entry
5.e
Date Location User Value Reason
Nov-24-2020
11:51:20ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID BS0JGInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138853
Page 129 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada): H
5.e Sample ID
Date Location User Value Reason
Nov-24-2020
11:51:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BS0JGHInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138854
Page 130 of 175
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Form Created
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138855
Page 131 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-28-2021
19:27:13
(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-02-2021
09:44:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-01-2021
21:20:27
(UTC-05:00)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answer
edCONFIRMED
THAT
INFORMATION
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138856
Page 132 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)IS CORRECT.
Jan-30-2021
21:31:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Please
confirm reported
Med Hx of type
2 diabetes
starting 2016
(age 31) in this
subject with
DKA
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
DIABETIC KET
OACIDOSISInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Jan/18/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-01-2021
08:29:14
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed end date
21Jan21
entered in
SAE
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138857
Page 133 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
Jan-30-2021
21:28:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical
Event end
date is
21Jan21;
however,
SAE report
has no end
date. Please
submit a SAE
safety update
reporting this
date in the
event STOP
date.
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date Time:
Jan/21/2021 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
3Initial Entry
7. Is the adverse event serious?
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138858
Page 134 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Mar-05-2021
19:51:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Clo
sedQuery closed; will
follow for requested
COVID test
information.
Mar-04-2021
16:11:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 3: Ans
weredCRC WILL UPDATE
TODAY. 03/04/2021
Mar-03-2021
21:18:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Rei
ssued:Opene
dClinical IF awaiting
additional records,
please submit
‘Awaiting Med
Records to Determine
if COVID testing was
Performed’ as a SAE
safety followup.
Thank you for your
efforts.
Feb-24-2021
08:42:11
(UTC-05:00)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 3: Ans
weredCRC HAS SENT IN
TWO MEDICAL
RECORDS
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138859
Page 135 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)REQUEST. WILL
REQUEST A THRID
TIME FOR
MEDICAL
RECORDS.
Feb-23-2021
13:23:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Rei
ssued:Opene
dClinical - Followup;
no SAE update since
28Jan21 and no
information about the
status of COVID
testing while in
hospital (No test, or
Yes test with date
/results). Please
update SAE report.
Feb-16-2021
13:25:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 3: Ans
weredCRC WILL UPDATE
ACCORDINGLY.
Feb-02-2021
18:32:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Rei
ssued:Opene
dClinical COVID test
status (yes/no) during
Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2021086899] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes,
the date and results.
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138860
Page 136 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-02-2021
18:32:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 4: Clo
sedResponse satisfies
query
Feb-02-2021
12:49:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Ans
weredChanged Information
Feb-02-2021
12:49:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Ans
weredChanged Information
Feb-02-2021
12:49:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Is this serio
us event ass
ociated wit
h congenita
l anomaly o
r birth defe
ct?
NO
Did this ser
ious event r
esult in deat
h?Changed Information
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138861
Page 137 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
NO
Did this ser
ious event r
equire or pr
olong hospi
talization?
YES
Did this ser
ious event r
esult in pers
istent or sig
nificant dis
ability/inca
pacity?
NO
Is this serio
us event lif
e threatenin
g?
NO
Other medi
cally impor
tant serious
event
NO
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138862
Page 138 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-30-2021
21:27:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 4: Ope
nedClinical Serious
criteria for event
DKA are
life-threatening and
Med
Important/Significant;
however, SAE
criterion is
Hospitalization.
Please review,
harmonize reporting,
and update where
appropriate.
Jan-30-2021
21:25:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Ope
nedClinical COVID test
status (yes/no) during
Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2021086899] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes,
the date and results.
Jan-29-2021
13:27:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Del
etedClose Auto Query
Jan-28-2021
21:30:00ACV0PFEINFP6000  auto query
(autoquery)Query 1: Clo
sedClose Auto Query
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138863
Page 139 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)
Jan-28-2021
21:30:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Is this serio
us event ass
ociated wit
h congenita
l anomaly o
r birth defe
ct?
NO
Did this ser
ious event r
esult in deat
h?
NO
Did this ser
ious event r
equire or pr
olong hospi
talization?
NO
Did this ser
ious event r
esult in pers
istent or sigTranscription Error
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138864
Page 140 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
nificant dis
ability/inca
pacity?
NO
Is this serio
us event lif
e threatenin
g?
YES
Other medi
cally impor
tant serious
event
YES
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Can
didateFor AE DIABETIC
KETOACIDOSIS:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ope
ned'Is the adverse event
serious?' is marked as
YES, but responses to
all of the seriousness
criteria are NO. At
least one seriousness
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138865
Page 141 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
criterion is expected
to be YES for serious
events. Please review
and update as
appropriate.
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Is this serio
us event ass
ociated wit
h congenita
l anomaly o
r birth defe
ct?
NO
Did this ser
ious event r
esult in deat
h?
NO
Did this ser
ious event r
equire or pr
olong hospi
talization?
NO
Did this ser
ious event rInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138866
Page 142 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
esult in pers
istent or sig
nificant dis
ability/inca
pacity?
NO
Is this serio
us event lif
e threatenin
g?
NO
Other medi
cally impor
tant serious
event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138867
Page 143 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Feb-02-2021
09:46:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-01-2021
21:22:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-01-2021
21:22:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHER
If Other, specif
y:
DIABETESChanged
Information
Jan-30-2021
21:29:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Other
cause for
event DKA
would not be
itself (DKA);
please review
underlying
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138868
Page 144 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
cause for
ketoacidosis
and update.
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHER
If Other, specif
y:
DIABETIC
KETOACID
OSISInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-28-2021 ACV0PFEINFP6000  Scott Salmon Data Entry: Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138869
Page 145 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.ssalmon) YES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-28-2021
19:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138870
Page 146 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-29-2021
13:27:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Gladys
Noi
(pfe.noig)Data Entry:
2021086899Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138871
Page 147 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-25-2020
08:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-25-2020
08:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-25-2020
08:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138872
Page 148 of 175
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021
10:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/1/2021Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138873
Page 149 of 175
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-03-2021
10:11:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Participant is willing
to return for Vaccinat
ion 3
Participant is:
eligible per other
protocol allowanc
e(s) and confirme
d to have received
only placebo at Va
ccination 1/2Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138874
Page 150 of 175
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-03-2021
10:11:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-03-2021
10:11:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138875
Page 151 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
08:18:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/12/2021Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138876
Page 152 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-16-2021
08:18:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/12/2021Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138877
Page 153 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-15-2021
09:57:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/12/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-15-2021
09:57:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-15-2021
09:57:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138878
Page 154 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-15-2021
09:58:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-15-2021
09:58:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-15-2021
09:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-15-2021
09:58:12
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138879
Page 155 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-15-2021
09:58:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Feb/12/2021Initial Entry
5.a
Date Location User Value Reason
Feb-15-2021
09:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR9V6
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-15-2021
09:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BR9V6PInitial Entry
5.b
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138880
Page 156 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Feb-15-2021
09:58:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR9V6
RInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-15-2021
09:58:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BR9V6RInitial Entry
5.c
Date Location User Value Reason
Feb-15-2021
09:58:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR9V6
SInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138881
Page 157 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Feb-15-2021
09:58:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BR9V6SInitial Entry
5.d
Date Location User Value Reason
Feb-15-2021
09:59:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BSLRW
XInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-15-2021
09:59:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BSLRWXInitial Entry
5.e
Date Location User Value Reason
Feb-15-2021
09:59:11ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I BSLRWInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138882
Page 158 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)D: Y
5.e Sample ID
Date Location User Value Reason
Feb-15-2021
09:59:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BSLRWYInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138883
Page 159 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021
08:19:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021
08:19:24
(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-17-2021
09:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-17-2021
08:18:47
(UTC-05:00)ACV0PFEINFP6000  Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138884
Page 160 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-16-2021
08:19:24
(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-16-2021
08:19:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Feb/12/2021Initial Entry
5.a
Date Location User Value Reason
Feb-17-2021
09:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR64C
KInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138885
Page 161 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-17-2021
09:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BR64CKInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138886
Page 162 of 175
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138887
Page 163 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/12/2021 11:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138888
Page 164 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
8. Actual Dose:
Date Location User Value Reason
Feb-16-2021
08:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-16-2021
08:19:56
(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-16-2021
08:19:56
(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-16-2021
08:19:56ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138889
Page 165 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138890
Page 166 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021
14:01:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/3/2021Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138891
Page 167 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021
14:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021
14:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-04-2021
15:05:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-04-2021
14:01:49
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138892
Page 168 of 175
***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, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-04-2021
14:01:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
Mar-04-2021
15:05:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR64L
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-04-2021
15:05:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BR64L5Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138893
Page 169 of 175
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138894
Page 170 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/3/2021 15:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138895
Page 171 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
8. Actual Dose:
Date Location User Value Reason
Mar-04-2021
14:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-04-2021
14:02:32
(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
Mar-04-2021
14:02:32
(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
Mar-04-2021
14:02:32ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138896
Page 172 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138897
Page 173 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-25-2020
08:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-07-2020
14:13:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-07-2020
14:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-25-2020
08:09:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/24/2020Initial Entry
Oct-07-2020
14:13:42ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138898
Page 174 of 175
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
Oct-07-2020
14:09:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138899
Page 175 of 175
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131656 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-07-2020
14:25:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae2f5c\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138900