Document text
Page 1 of 204
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137622
Page 2 of 204
***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: 10131255 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
Aug/20/2020
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137623
Page 3 of 204
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131255]
2.Birth Date: /1990
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137624
Page 4 of 204
***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: 10131255 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 Aug/20/2020
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137625
Page 5 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137626
Page 6 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137627
Page 7 of 204
***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: 10131255 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:[WISDOM TEETH REMOVAL]
Start Date: May/UNK/2016
Ongoing: NO
End Date:
May/UNK/2016
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137628
Page 8 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [60.5]
3.Unit: kg
4.Height: [178.0]
5.Unit: cm
6.Body Mass Index: [19.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [35.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137629
Page 9 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/20/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137630
Page 10 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [58170]
3.Randomization Group: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137631
Page 11 of 204
***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: 10131255 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:
Aug/20/2020
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 [BPYXBB]
5.bSample ID [BPYXBC]
5.cSample ID [BPYXBD]
5.dSample ID [BNWHN8]
5.eSample ID [BNWHN9]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137632
Page 12 of 204
***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: 10131255 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:
Aug/20/2020
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 [BM8S83]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137633
Page 13 of 204
***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: 10131255 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: Aug/20/2020 10:10
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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137634
Page 14 of 204
***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: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137635
Page 15 of 204
***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: 10131255 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 Sep/10/2020
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137636
Page 16 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137637
Page 17 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/10/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137638
Page 18 of 204
***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: 10131255 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:
Sep/10/2020
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 [BPC2WJ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137639
Page 19 of 204
***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: 10131255 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: Sep/10/2020 15:50
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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137640
Page 20 of 204
***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: 10131255 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/14/2020
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137641
Page 21 of 204
***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: 10131255 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/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9TT7]
5.bSample ID [BR9TT8]
5.cSample ID [BR9TT9]
5.dSample ID [BMN59G]
5.eSample ID [BMN59H]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137642
Page 22 of 204
***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: 10131255 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:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137643
Page 23 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137644
Page 24 of 204
***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: 10131255 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 [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137645
Page 25 of 204
***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: 10131255 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 [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137646
Page 26 of 204
***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: 10131255 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?
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137647
Page 27 of 204
***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: 10131255 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:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137648
Page 28 of 204
***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: 10131255 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:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137649
Page 29 of 204
***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: 10131255 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 [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137650
Page 30 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137651
Page 31 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137652
Page 32 of 204
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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 :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137653
Page 33 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137654
Page 34 of 204
***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: 10131255 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:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137655
Page 35 of 204
***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: 10131255 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 [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137656
Page 36 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 EXPOSURE DURI
NG PREGNANCY
Sep/UNK/20
20 UNK:UN
K NO
End Date Time:
Oct/UNK/2020
UNK:UNK
Repeating
Pages
2.ADVERS
E EVENT
2 MISCARRIAGE Oct/UNK/20
20 UNK:UN
K NO
End Date Time:
Oct/UNK/2020
UNK:UNK
Repeating
Pages
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137657
Page 37 of 204
***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: 10131255 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)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Sep/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/UNK/2020 UNK:UNK
6.Toxicity Grade: Not Applicable Comments
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137658
Page 38 of 204
***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: 10131255 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[PREGNANCY WITH MISCARRIAGE]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137659
Page 39 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137660
Page 40 of 204
***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: 10131255 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: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[MISCARRIAGE]
4.Start Date Time: Oct/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/UNK/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137661
Page 41 of 204
***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: 10131255 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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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:
[MISCARRIAGE]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137662
Page 42 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020503978]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137663
Page 43 of 204
***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: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137664
Page 44 of 204
***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: 10131255 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[ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137665
Page 45 of 204
***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: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137666
Page 46 of 204
***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: 10131255 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: //
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137667
Page 47 of 204
***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: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137668
Page 48 of 204
***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: 10131255 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?
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137669
Page 49 of 204
***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: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137670
Page 50 of 204
***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: 10131255 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?
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137671
Page 51 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137672
Page 52 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137673
Page 53 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137674
Page 54 of 204
***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: 10131255 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:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137675
Page 55 of 204
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137676
Page 56 of 204
***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: 10131255 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?
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137677
Page 57 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137678
Page 58 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137679
Page 59 of 204
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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/10/2021
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137680
Page 60 of 204
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137681
Page 61 of 204
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/10/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137682
Page 62 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137683
Page 63 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137684
Page 64 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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/10/2021
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137685
Page 65 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Mar/10/2021
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137686
Page 66 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137687
Page 67 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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 :Mar/10/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137688
Page 68 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137689
Page 69 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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:
Mar/10/2021
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 [BV0XPK]
5.bSample ID [BV0XPL]
5.cSample ID [BV0XPM]
5.dSample ID [BVSYTW]
5.eSample ID [BVSYTX]
5.fSample ID [ ]
5.gSample ID [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137690
Page 70 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.hSample ID [ ]
5.iSample ID [ ]
5.jSample ID [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137691
Page 71 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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/10/2021
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 [BV0PGC]
5.bSample ID [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137692
Page 72 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Incomplete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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?YES
Date of First Delay:
Mar/10/2021
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY 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?
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137693
Page 73 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137694
Page 74 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137695
Page 75 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10131255 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 [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137696
Page 76 of 204
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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?
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137697
Page 77 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137698
Page 78 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137699
Page 79 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137700
Page 80 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137701
Page 81 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137702
Page 82 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137703
Page 83 of 204
***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: 10131255 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: [ ]
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137704
Page 84 of 204
***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: 10131255 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 Oct/14/2020
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137705
Page 85 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137706
Page 86 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137707
Page 87 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-20-2020 13:14:28
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137708
Page 88 of 204
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Feb-09-2021 09:58:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137709
Page 89 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-12-2021 11:31:23 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137710
Page 90 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137711
Page 91 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137712
Page 92 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137713
Page 93 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137714
Page 94 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Mar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137715
Page 95 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Mar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137716
Page 96 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aMar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137717
Page 97 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aMar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137718
Page 98 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aMar-12-2021 11:32:00 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137719
Page 99 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
Scott
Salmon N/A Mar-12-2021 11:29:44 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Brown Approved Feb-25-2021 13:48:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
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-09-2021 09:57:57 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137720
Page 100 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
N/A
Michael
Dever Approved Feb-04-2021 12:59:21 (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.
Pamela
Benne prod N/A Feb-03-2021 09:29:06 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-02-2021 11:05:14 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137721
Page 101 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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 Feb-01-2021 12:22:15 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-01-2021 10:16:31 (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.
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137722
Page 102 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Scott
Salmon N/A Jan-27-2021 15:04:11 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Jan-21-2021 09:23:04 (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.
Matthew
Stephens N/A Dec-23-2020 11:13:15 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Oct-21-2020 12:39:18 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137723
Page 103 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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.
Matthew
Stephens N/A Oct-14-2020 17:18:39 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Oct-06-2020 06:39:05 (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.
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137724
Page 104 of 204
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Aug-20-2020
13:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-20-2020
13:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137725
Page 105 of 204
***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: 10131255 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
Aug-20-2020
13:13:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/20/2020Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137726
Page 106 of 204
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Aug-20-2020
13:13:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10131255Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020
13:13:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1990Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020
13:14:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137727
Page 107 of 204
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-20-2020
13:14:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020
13:14:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
WHITEInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137728
Page 108 of 204
***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: 10131255 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
Aug-20-2020
13:14:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/20/2020Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137729
Page 109 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Aug-20-2020
13:14:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020
13:14:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020
13:14:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137730
Page 110 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020
13:15:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:1
Medical
History
Term:WISDOM T
EETH REM
OVAL
Start Da
te:May/UNK/2
016
Ongoing
:NO
End Date:
May/UN
K/2016Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020
13:15:06
(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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137731
Page 111 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-20-2020
13:15:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
WISDOM TEETH
REMOVALInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-20-2020
13:15:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
May/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-20-2020
13:15:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NO
End Date:
May/UNK/2016Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137732
Page 112 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
60.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137733
Page 113 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
178.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19.1Initial Entry
7.a
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:35.7Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137734
Page 114 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020
03:08:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ankita Thakur
(pfe.thakua20)Query 1: Closed Closed by DM:
AT.
Aug-20-2020
13:16:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 1: Answe
redCORRECT AS
RECORDED.
PER
INVESTIGATOR
WITHIN
NORMAL
LIMITS
Aug-20-2020 ACV0PFEINFP6000 auto query Query 1: Opene Temperature 35.7
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137735
Page 115 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13:15:37
(UTC-05:00)
Eastern Time
(US & Canada)(autoquery) d C is outside of
Normal Range
36.1 - 37.5 C.
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
35.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020
13:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137736
Page 116 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137737
Page 117 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137738
Page 118 of 204
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020
13:16:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137739
Page 119 of 204
***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: 10131255 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
Aug-20-2020
13:16:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020
13:16:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
58170Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137740
Page 120 of 204
***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: 10131255 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
Aug-20-2020
13:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
13:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020
17:07:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-20-2020
13:16:42
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137741
Page 121 of 204
***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: 10131255 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.
Aug-20-2020
13:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020
17:07:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPYXB
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020
17:07:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPYXBBInitial Entry
5.b
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137742
Page 122 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-20-2020
17:07:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPYXB
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-20-2020
17:07:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPYXBCInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020
17:07:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPYXB
DInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137743
Page 123 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Aug-20-2020
17:07:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPYXBDInitial Entry
5.d
Date Location User Value Reason
Aug-20-2020
17:07:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BNWH
N8Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-20-2020
17:07:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BNWHN8Initial Entry
5.e
Date Location User Value Reason
Aug-20-2020
17:07:27ACV0PFEINFP6000 Matthew
StephensData Entry:
Sample I BNWHInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137744
Page 124 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: N9
5.e Sample ID
Date Location User Value Reason
Aug-20-2020
17:07:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BNWHN9Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137745
Page 125 of 204
***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: 10131255 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
Aug-20-2020
13:16:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
13:16:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020
17:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-20-2020
13:16:49
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137746
Page 126 of 204
***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: 10131255 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.
Aug-20-2020
13:16:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020
17:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BM8S8
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020
17:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8S83Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137747
Page 127 of 204
***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: 10131255 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
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137748
Page 128 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/20/2020 10:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137749
Page 129 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020
13:17:00
(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
Aug-20-2020
13:17:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137750
Page 130 of 204
***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: 10131255 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
Aug-20-2020
13:17:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137751
Page 131 of 204
***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: 10131255 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
Sep-10-2020
16:34:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/10/2020Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137752
Page 132 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020
16:34:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020
16:34:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.1
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
16:34:26
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
1Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137753
Page 133 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-10-2020
16:34:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020
16:34:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
16:34:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137754
Page 134 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137755
Page 135 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137756
Page 136 of 204
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020
16:34:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137757
Page 137 of 204
***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: 10131255 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
Sep-10-2020
16:34:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
16:34:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
17:04:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
16:34:47
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137758
Page 138 of 204
***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: 10131255 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.
Sep-10-2020
16:34:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
YES
Date of Collection
:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
17:04:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2
WJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
17:04:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2WJInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137759
Page 139 of 204
***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: 10131255 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
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137760
Page 140 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/10/2020 15:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137761
Page 141 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020
16:35:07
(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
Sep-10-2020
16:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
YESInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137762
Page 142 of 204
***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: 10131255 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-14-2020
17:18:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/14/2020Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137763
Page 143 of 204
***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: 10131255 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-14-2020
17:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
17:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
08:33:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-15-2020
04:44:55
(UTC-05:00)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137764
Page 144 of 204
***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: 10131255 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-14-2020
17:18:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
17:18:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
08:33:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TT
7Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137765
Page 145 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-15-2020
08:33:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TT7Initial Entry
5.b
Date Location User Value Reason
Oct-15-2020
08:33:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TT
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
08:33:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TT8Initial Entry
5.c
Date Location User Value Reason
Oct-15-2020
08:33:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TT
9Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137766
Page 146 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
08:33:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TT9Initial Entry
5.d
Date Location User Value Reason
Oct-15-2020
08:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BMN59
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-15-2020
08:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN59GInitial Entry
5.e
Date Location User Value Reason
Oct-15-2020
08:33:39ACV0PFEINFP6000 Matthew
StephensData Entry:
Sample I BMN59Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137767
Page 147 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: H
5.e Sample ID
Date Location User Value Reason
Oct-15-2020
08:33:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN59HInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137768
Page 148 of 204
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-14-2020
17:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
17:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
17:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137769
Page 149 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Form Created
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137770
Page 150 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Form Created
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137771
Page 151 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-23-2020
11:13:15
(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-23-2021
16:04:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3:
ClosedClinical - thank you;
however date of contact /
notification of event was
not added in the most recent
SAE update, e.g at "During
this call, the subject
mentioned …..". Please
submit a safety update
reporting this date
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137772
Page 152 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-17-2021
08:17:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 3:
Answere
dCRC WILL UPDATE
ACCORDINGLY.
Feb-15-2021
22:24:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3:
OpenedCLINICAL Please submit a
SAE update reporting the
date when site contacted the
subject (to review diary
compliance) and the subject
informed the site re
pregnancy and miscarriage
Feb-03-2021
09:34:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Query 2:
ClosedResponse satisfies query
Feb-01-2021
12:22:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answere
dChanged Information
Feb-01-2021
12:22:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data En
try:
EXPOS
URE D
URING
PREGNChanged Information
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137773
Page 153 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
ANCY
Feb-01-2021
10:49:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Query 2:
OpenedSAE
RECON:AER#2020503978,
the term in AE CRF was
recorded as 'PREGNANCY
WITH MISCARRIAGE'
while reported as
MISCARRIAGE in SDB.
Please confirm correct term.
If safety update is required,
please submit a follow-up
form.
Jan-29-2021
13:31:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1:
ClosedClinical Thank you;
however the event terms
need to be split on 2 lines:
Miscarriage (SAE) and
Exposure during Pregnancy
(not a SAE). Info currently
is correct for EDP section.
Jan-27-2021
15:00:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 1:
Answere
dUPDATED AE
Jan-12-2021
14:23:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1:
OpenedCLINICAL Event term is
Pregnancy with
Miscarriage; however, SAE
event term is Miscarriage.
As pregnancy is not an AE
(although reported on AE
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137774
Page 154 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
log), please harmonize on
SAE term of miscarriage;
earlier PG info will be
retained
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data En
try:
PREGN
ANCY
WITH
MISCA
RRIAG
EInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021
01:31:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1:
ClosedSafety specifications
include EDP (non-serious
event) with Miscarriage
SAE
Feb-03-2021
09:38:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Query 1:
Reissued
:OpenedEXPOSURE DURING
PREGNANCY not in SDB
only miscarriage
Feb-02-2021
10:09:24
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2:
ClosedResponse satisfies query
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137775
Page 155 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US &
Canada)
Feb-01-2021
12:28:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 1:
Answere
dUPDATED
Jan-28-2021
10:01:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Gladys Noi
(pfe.noig)Query 1:
Reissued
:OpenedSAE RECON 1: Thanks for
the response. Please
consider submitting an
updated SAE form to
update the Onset date in
safety database with the
Month since its recorded as
only 2020 in Safety
database.
Jan-27-2021
15:04:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data En
try:
Sep/UN
K/2020
UNK:U
NKChanged Information
Jan-27-2021
15:01:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 2:
Answere
dAE UPDATED
Jan-27-2021
14:56:13ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 1:
AnswereSEPTEMBER 2020
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137776
Page 156 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US &
Canada)d
Jan-12-2021
14:20:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2:
OpenedCLINICAL Start date is
UNK; however, SAE report
for event Miscarriage
reports Start of event on
22Dec20. Please review,
harmonize reporting and
update where applicable
Jan-08-2021
07:25:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1:
OpenedSAE
RECON:AER#2020503978,
the onset date is blank in
Safety database while
recorded as UNK/UNK
/2020. Please confirm if the
month and year at least can
be provided for the onset
date.
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data En
try:
UNK/U
NK/202
0 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-02-2021
10:09:00ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137777
Page 157 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)
Jan-27-2021
15:04:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date Time:
Oct/UNK/2020
UNK:UNKChanged
Information
Jan-27-2021
14:59:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 2: Answere
dUPDATED AE
FORM
Jan-26-2021
11:47:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL
End date is
UNK;
however,
original SAE
report for
event
Miscarriage
was on
18Dec20, so
End date
before that.
Please review
and update
End Month if
possible in
both AE/SAE
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137778
Page 158 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-26-2021
11:46:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed rewording
Jan-12-2021
14:19:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL
End date is
UNK;
however, SAE
report for
event
Miscarriage
reports end of
event on
22Dec20.
Please review,
harmonize
reporting and
update where
applicable
Dec-23-2020
12:49:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NO
End Date Time:
UNK/UNK/20
20 UNK:UNKTranscription
Error
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137779
Page 159 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
6. Toxicity Grade:
Date Location User Value Reason
Feb-09-2021
09:58:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
Feb-09-2021
09:57:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry: Changed
Information
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-04-2021
12:17:19
(UTC-05:00)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Clos
edResponse satisfies
query
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137780
Page 160 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)
Feb-03-2021
09:35:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Dele
tedClose Auto Query
Feb-02-2021
10:08:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Reis
sued:OpenedClinical Thank you;
however, SAE
report #2020503978
reports the event as
SERIOUS due to
Medically
important/significant
criterion. Please
review serious
status, harmonize
reporting, and
update where
appropriate
Feb-01-2021
12:22:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Can
didateFor AE EXPOSURE
DURING
PREGNANCY:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Jan-27-2021
15:05:25ACV0PFEINFP6000 auto query
(autoquery)Query 3: Can
didateFor AE
PREGNANCY
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137781
Page 161 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)WITH
MISCARRIAGE:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Jan-27-2021
15:05:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOChanged
Information
Jan-27-2021
14:54:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 2: Ans
weredUPDATED AE
Jan-04-2021
07:17:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Dele
tedClose Auto Query
Dec-23-2020
15:38:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Ope
nedClinical - Event
criteria for serious is
Hospitalization;
however, SAE
report has event
criteria for serious
as Medically
Important. Please
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137782
Page 162 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
review, harmonize
reporting, and
update in the
required location.
Note, reporting 2
criteria is
acceptable.
Dec-23-2020
12:49:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Can
didateFor AE
PREGNANCY
WITH
MISCARRIAGE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-23-2020
12:49:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Is this seriou
s event assoc
iated with co
ngenital ano
maly or birth
defect?
NO
Did this seri
ous event res
ult in death?
NOTranscription Error
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137783
Page 163 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Did this seri
ous event re
quire or prol
ong hospitali
zation?
YES
Did this seri
ous event res
ult in persist
ent or signifi
cant disabilit
y/incapacity
?
NO
Is this seriou
s event life t
hreatening?
NO
Other medic
ally importa
nt serious ev
ent
NO
Dec-23-2020
11:13:15
(UTC-05:00)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137784
Page 164 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-27-2021
13:20:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed contraception
method
submitted to
SAE
Jan-12-2021
14:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical Please
submit a SAE
safety update
specifying the
contraceptive
method(s) this
subject was
utilizing when
conception
occurred
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137785
Page 165 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-12-2021
14:31:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed SAE update
received with
this info
Jan-08-2021
12:49:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL
Please
complete the
supplement
Exposure
during
Pregnancy
form for
information
on subject
prior to
miscarriage,
and Paternal
information if
available; also
pregnancy
outcome
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137786
Page 166 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
OTHER
If Other, speci
fy:
PREGNAN
CY WITH
MISCARRI
AGE
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137787
Page 167 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-23-2020
12:50:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Cl
osedClose Auto Query
Dec-23-2020
12:50:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry
:
RECOVER
ED/RESOL
VEDTranscription Error
Dec-23-2020
12:49:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: O
penedFor AE
PREGNANCY WITH
MISCARRIAGE:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Dec-23-2020 ACV0PFEINFP6000 Matthew Data Entry Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137788
Page 168 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11:13:15
(UTC-05:00)
Eastern Time
(US &
Canada)Stephens
(pfe.mstephens):
RECOVER
ING/RESO
LVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-23-2020
11:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-03-2021
09:35:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Data Entry: New
Information
Jan-04-2021
07:17:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020503978Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137789
Page 169 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021
11:38:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Mar-01-2021
16:35:37ACV0PFEINFP6000 Matthew
StephensQuery 1: Answer
edCRC WILL
UPDATE SAE
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137790
Page 170 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)(pfe.mstephens) NARRATIVE.
Feb-26-2021
10:49:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Sathenapalli
Suguna Srujan
(pfe.srujas)Query 1: Opened Clinical -
Miscarriage
SAE narrative
states that site
RA contacted
subject & was
told about the
miscarriage.
Please update
the SAE
narrative with
the date of this
call
Feb-25-2021
09:37:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Candida
teClinical -
Miscarriage
SAE narrative
states that site
RA contacted
subject & was
told about the
miscarriage.
Please update
the SAE
narrative with
the date of this
call
Feb-01-2021
12:26:08
(UTC-05:00)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
MISCARRIAGEInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137791
Page 171 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)
4. Start Date Time:
Date Location User Value Reason
Feb-22-2021
16:52:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Gladys Noi
(pfe.noig)Query 3:
ClosedOnset date updated to
UNK/OCT/2020 in SDB
Feb-18-2021
01:56:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 3:
OpenedSAE
RECON:AER#2020503978,
the onset date is updated to
10OCT2020 in Safety
database while recorded as
UNK/OCT/2020. Please
confirm correct date. If
safety update is required,
please submit a follow-up
form or update Inform.
Feb-09-2021
01:25:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2:
ClosedSAE start date updated to
??Oct2020
Feb-08-2021
08:12:32
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Query 1:
Closedupdated dates
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137792
Page 172 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US &
Canada)
Feb-04-2021
12:15:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2:
OpenedClinical Start date is
UNK/Oct/2020; however in
Miscarriage SAE
(#2020503978), event start
date is UNK/Sep/2020.
Please review start date;
harmonize reporting, &
update where required
Feb-03-2021
09:31:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Query 1:
OpenedSAE
RECON:AER#2020503978,
the onset date is
UNK/SEP/2020 in Safety
database while recorded as
UNK/OCT/2020. Please
confirm dates. If safety
update is required, please
submit a follow-up form or
update Inform.
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Ent
ry:
Oct/UNK
/2020 U
NK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-04-2021
12:14:06ACV0PFEINFP6000 Kathryn
SewellQuery 1: Closed rewording
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137793
Page 173 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)(pfe.sewelk02)
Feb-04-2021
12:12:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical In
Miscarriage
SAE
(#2020503978),
event start/end
dates are
UNK/Nov/2020.
Please review
dates here & in
SAE; harmonize
reporting, &
update where
required
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date Time:
Oct/UNK/202
0 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
3Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137794
Page 174 of 204
***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: 10131255 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).
Date Location User Value Reason
Feb-03-2021
09:29:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eFor AE
MISCARRIAGE:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Is this serious ev
ent associated w
ith congenital an
omaly or birth d
efect?Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137795
Page 175 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospitali
zation?
NO
Did this serious
event result in p
ersistent or signi
ficant disability/i
ncapacity?
NO
Is this serious ev
ent life threateni
ng?
NO
Other medically
important seriou
s event
YES
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137796
Page 176 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
MISCARRIAG
EInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137797
Page 177 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-01-2021
12:26:08
(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
Feb-01-2021
12:26:08
(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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137798
Page 178 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-01-2021
12:26:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-03-2021
09:29:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Data Entry:
2020503978Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137799
Page 179 of 204
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-12-2021
11:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/10/2021Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137800
Page 180 of 204
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Mar-12-2021
11:30:18
(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
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137801
Page 181 of 204
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Mar-12-2021
11:29:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/10/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-12-2021
11:29:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137802
Page 182 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-12-2021
11:30:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/10/2021Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137803
Page 183 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Mar-12-2021
11:31:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Mar/10/2021Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137804
Page 184 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Mar-12-2021
11:31:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021
11:31:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021
11:31:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137805
Page 185 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137806
Page 186 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137807
Page 187 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
6.a Sponsor ID:
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Mar-12-2021
11:32:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Mar-12-2021
11:32:00ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137808
Page 188 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137809
Page 189 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-12-2021
11:32:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
11:32:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
14:03:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
11:32:19
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137810
Page 190 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-12-2021
11:32:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
14:03:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BV0XP
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
14:03:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BV0XPKInitial Entry
5.b
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137811
Page 191 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Mar-12-2021
14:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BV0XP
LInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
14:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BV0XPLInitial Entry
5.c
Date Location User Value Reason
Mar-12-2021
14:03:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BV0XP
MInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137812
Page 192 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
14:03:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BV0XPMInitial Entry
5.d
Date Location User Value Reason
Mar-12-2021
14:04:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BVSYT
WInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-12-2021
14:04:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BVSYTWInitial Entry
5.e
Date Location User Value Reason
Mar-12-2021
14:05:10ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I BVSYTInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137813
Page 193 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)D: X
5.e Sample ID
Date Location User Value Reason
Mar-12-2021
14:05:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BVSYTXInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137814
Page 194 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-12-2021
11:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
11:32:35
(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-12-2021
14:16:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
11:32:35
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137815
Page 195 of 204
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-12-2021
11:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
14:16:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BV0PG
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
14:16:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BV0PGCInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137816
Page 196 of 204
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Incomplete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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-12-2021
11:34:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of First Delay:
Mar/10/2021
Reason(s) for Temp
orary Delay of Vacc
ination
RECENT NON-S
TUDY VACCINA
TIONInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137817
Page 197 of 204
***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: 10131255 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
Oct-14-2020
17:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020
13:16:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-20-2020
13:14:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-27-2021
13:09:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Clos
edDSU querying date of
phone call, with is date PI
is first aware of event
Jan-27-2021 ACV0PFEINFP6000 Kathryn Sewell Query Response satisfies query
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137818
Page 198 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13:07:33
(UTC-05:00)
Eastern Time
(US &
Canada)(pfe.sewelk02) 4: Clos
ed
Jan-06-2021
15:05:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query
1: Clos
edResponse satisfies query
Jan-05-2021
15:13:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query
1: Ans
weredPER CRC, SUBJECT
REPORTED IN ERROR.
Jan-05-2021
00:37:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query
1: Reis
sued:O
penedRQ: Thank you for the
response. Please consider
to follow-up and confirm
for reported Illness eDiary
response of 01DEC2020.
Please update or clarify.
Dec-31-2020
04:35:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Swapna Varikuti
(pfe.variks)Query
1: Reis
sued:C
andidat
eRQ1: Thank you for the
response, please confirm if
the COVID visit is
scheduled for symptoms
reported on 01DEC2020
and update the details
accordingly , else clarify.
Dec-30-2020
14:04:36ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query
1: AnsAttempting to contact
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137819
Page 199 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US &
Canada)wered
Dec-30-2020
04:37:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Sonal K
(pfe.ks66)Query
1: Reis
sued:O
penedRQ1: Thank you for the
response, please confirm if
the COVID visit is
scheduled for symptoms
reported on 01DEC2020
and update the details
accordingly , else clarify.
Dec-23-2020
17:32:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
4: Reis
sued:O
penedClinical Please send the
parent pregnancy info in a
SAE update FAX (LMP
date, prior pregnancies &
outcome, father age,
mother & father
smoke/alcohol/illicit drugs,
contraceptive method,
other info)
Dec-23-2020
17:26:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Reis
sued:O
penedClinical Thank you; please
send the information on the
date of the notification
phone call in a SAE update
FAX
Dec-23-2020
17:24:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
5: Clos
edevent entered on AE CRF
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137820
Page 200 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-23-2020
17:23:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
2: Clos
edResponse satisfies query
Dec-23-2020
11:14:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query
5: Ans
weredChanged data per query
Dec-23-2020
11:13:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query
4: Ans
weredChanged data per query
Dec-23-2020
11:13:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query
3: Ans
weredChanged data per query
Dec-23-2020
11:13:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query
2: Ans
weredChanged data per query
Dec-22-2020
09:24:33ACV0PFEINFP6000 Ricell Ann Piojo
(pfe.quitor)Query
5: OpeSAE
RECON:AER#2020503978
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137821
Page 201 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US &
Canada)ned pregnany resulting in
miscarriage was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Dec-21-2020
16:10:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
4: Ope
nedClinical Please complete
the Parent Pregnancy
Information section on the
SAE form, to clarify
previous obstetric and
delivery history.
Dec-21-2020
16:08:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Ope
nedCLINICAL SAE report
states that subject informed
the site of the event on a
phone call, when research
asst called about diary
compliance. However, date
of the call is missing;
please submit a SAE
update with the date of the
phone contact.
Dec-21-2020
16:05:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
2: Ope
nedCLINICAL SAE report
(#2020503978) states
subject had a miscarriage
'between visit 2 and visit 3'.
Please enter the event on
the AE CRF.
Dec-16-2020
03:48:31ACV0PFEINFP6000 Nancy
VedamuthuQuery
1: ReisQuery response indicate
NOT BEEN ABLE GET
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137822
Page 202 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US &
Canada)(pfe.vedamn) sued:C
andidat
eIN CONTACT. Please
query after 2 days to
confirm whether Cov ill
visit done or not.
Dec-15-2020
08:51:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query
1: Ans
weredCRC CANNOT
CONFIRM WITH
SUBJECT AS THEY
HAVE NOT BEEN ABLE
GET IN CONTACT
WITH.
Dec-15-2020
00:42:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query
1: Reis
sued:O
penedRQ1: Thank you for the
response. Please consider
to follow-up and confirm
for reported Illness eDiary
response of 01DEC2020.
Please update or clarify.
Dec-14-2020
10:04:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query
1: Ans
weredPER CRC, STILL
TRYING TO GET IN
CONTACT WITH
SUBJECT TO CONFIRM
SYMPTOMS.
Dec-08-2020
08:08:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Sharat Nair
(pfe.nairs51)Query
1: Ope
nedIllness ediary: As per
Illness ediary records,
subject reported "Yes" for
the question "Have you
experienced any of the
following?” for the
COVID-19 symptoms or
diagnosis on 01DEC2020.
But corresponding COVID
Illness visit not reported.
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137823
Page 203 of 204
***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: 10131255 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Please clarify.
Oct-14-2020
17:19:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data E
ntry:
Oct/14/
2020Initial Entry
Aug-20-2020
13:16:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data E
ntry:
Aug/20
/2020Initial Entry
Aug-20-2020
13:14:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data E
ntry:
Aug/20
/2020Initial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137824
Page 204 of 204
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131255 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
Sep-15-2020
10:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f58\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137825