Document text
Page 1 of 144
***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: 10131517 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
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137943
Page 2 of 144
***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: 10131517 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
Sep/10/2020
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137944
Page 3 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131517]
2.Birth Date: 1950
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137945
Page 4 of 144
***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: 10131517 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
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137946
Page 5 of 144
***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: 10131517 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
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137947
Page 6 of 144
***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: 10131517 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
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137948
Page 7 of 144
***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: 10131517 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:[VITILIGO]
Start Date: UNK/UNK/1978
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ASTHMA]
Start Date: UNK/UNK/1951
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MYOCARDIAL INFARCTION]
Start Date: Feb/14/2016
Ongoing: NO
End Date:
Feb/14/2016
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[STENT CARDIAC INSERTION]
Start Date: Feb/14/2016
Ongoing: NO
End Date:
Feb/14/2016
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137949
Page 8 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROIDISM]
Start Date: UNK/UNK/2016
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137950
Page 9 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
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: 10131517 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
2.Weight: [77.1]
3.Unit: kg
4.Height: [182.8]
5.Unit: cm
6.Body Mass Index: [23.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137951
Page 10 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [256937]
3.Randomization Group: [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137952
Page 11 of 144
***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: 10131517 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:
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 [BN62J2]
5.bSample ID [BN62J3]
5.cSample ID [BN62J4]
5.dSample ID [BMN4KP]
5.eSample ID [BMN4KR]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137953
Page 12 of 144
***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: 10131517 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 [BPC2W4]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137954
Page 13 of 144
***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: 10131517 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 13:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137955
Page 14 of 144
***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: 10131517 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
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137956
Page 15 of 144
***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: 10131517 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/30/2020
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137957
Page 16 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137958
Page 17 of 144
***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: 10131517 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/30/2020
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 [BRG2PB]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137959
Page 18 of 144
***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: 10131517 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/30/2020 14:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137960
Page 19 of 144
***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: 10131517 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/28/2020
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137961
Page 20 of 144
***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: 10131517 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/28/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR640M]
5.bSample ID [BR640N]
5.cSample ID [BR640P]
5.dSample ID [BSHPSR]
5.eSample ID [BSHPSS]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137962
Page 21 of 144
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137963
Page 22 of 144
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137964
Page 23 of 144
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137965
Page 24 of 144
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137966
Page 25 of 144
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137967
Page 26 of 144
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137968
Page 27 of 144
***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: 10131517 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:
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137969
Page 28 of 144
***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: 10131517 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: [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137970
Page 29 of 144
***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: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137971
Page 30 of 144
***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: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137972
Page 31 of 144
***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: 10131517 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?
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Page 32 of 144
***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: 10131517 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:
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***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: 10131517 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:
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Page 34 of 144
***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: 10131517 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 [ ]
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FDA-CBER-2021-5683-0137976
Page 35 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137977
Page 36 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
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Page 37 of 144
***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: 10131517 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/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0137979
Page 38 of 144
***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: 10131517 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: [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137980
Page 39 of 144
***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: 10131517 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:
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FDA-CBER-2021-5683-0137981
Page 40 of 144
***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: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137982
Page 41 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
1.ADVERSE E
VENT 1 INJECTION SITE PAIN T
O LEFT ARM Sep/10/2020 07
:00 NO
End Date Time:
Sep/11/2020 08:00
Repeating
Pages
2.ADVERSE E
VENT 2 FATIGUE Sep/11/2020 07
:00 NO
End Date Time:
Sep/11/2020 19:00
Repeating
Pages
3.ADVERSE E
VENT 3 STEMI Nov/8/2020 U
NK:UNK NO
End Date Time:
Nov/10/2020 UNK:U
NK
Repeating
Pages
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137983
Page 42 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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)[INJECTION SITE PAIN TO LEFT ARM]
4.Start Date Time: Sep/10/2020 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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FDA-CBER-2021-5683-0137984
Page 43 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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[ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137985
Page 44 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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)[FATIGUE]
4.Start Date Time: Sep/11/2020 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 19:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137986
Page 45 of 144
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137987
Page 46 of 144
***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: 10131517 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[STEMI]
4.Start Date Time: Nov/8/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/10/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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Page 47 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
[CORONARY ARTERY DISEASE]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020453470]
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FDA-CBER-2021-5683-0137989
Page 48 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137990
Page 49 of 144
***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: 10131517 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[ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137991
Page 50 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137992
Page 51 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
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FDA-CBER-2021-5683-0137993
Page 52 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137994
Page 53 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
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FDA-CBER-2021-5683-0137995
Page 54 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
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FDA-CBER-2021-5683-0137996
Page 55 of 144
***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: 10131517 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?
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137997
Page 56 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137998
Page 57 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0137999
Page 58 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138000
Page 59 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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FDA-CBER-2021-5683-0138001
Page 60 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 10131517 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?
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138002
Page 61 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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: [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138003
Page 62 of 144
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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: [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138004
Page 63 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138005
Page 64 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138006
Page 65 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138007
Page 66 of 144
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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 [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138008
Page 67 of 144
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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 Jan/5/2021
2.Erroneous Visit
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138009
Page 68 of 144
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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 and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138010
Page 69 of 144
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138011
Page 70 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138012
Page 71 of 144
***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: 10131517 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: [ ]
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138013
Page 72 of 144
***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: 10131517 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/28/2020
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138014
Page 73 of 144
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138015
Page 74 of 144
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael Dever Approved Jan-26-2021 07:13:56 (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.
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138016
Page 75 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-10-2020 13:38:16 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138017
Page 76 of 144
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael Dever Approved Jan-26-2021 07:13:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Scott Salmon N/A Jan-22-2021 08:21:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Jan-20-2021 12:30:34 (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-02-2020 13:52:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138018
Page 77 of 144
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Michael Dever Approved Nov-17-2020 16:40:54 (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.
Ricell Ann
Piojo N/A Nov-17-2020 05:57:42 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Nov-16-2020 16:22:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Scott Salmon N/A Nov-16-2020 11:19:43 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Nov-02-2020 10:23:48 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138019
Page 78 of 144
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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.
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138020
Page 79 of 144
***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: 10131517 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
Sep-10-2020 13:37:34
(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
Sep-10-2020 13:37:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138021
Page 80 of 144
***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: 10131517 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
Sep-10-2020 13:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/10/2020Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138022
Page 81 of 144
***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: 10131517 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
Sep-10-2020 13:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10131517Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020 13:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1950Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020 13:37:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 13:37:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 13:37:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
WHITEInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
FDA-CBER-2021-5683-0138023
Page 82 of 144
***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: 10131517 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 13:38:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138024
Page 83 of 144
***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: 10131517 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
Sep-10-2020 13:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020 13:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020 13:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138025
Page 84 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Sep-11-2020 07:49:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:VITILIGO
Start Date: UNK/UNK
/1978
Ongoing: YESTranscription Error
Sep-10-2020 13:38:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:VITALIG
O
Start Date: UNK/UNK
/1978
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:38:42
(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
Sep-11-2020
21:35:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Cl
osedDiscrepancy
has been
closed.
Sep-11-2020
07:49:04ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredTranscription
Error
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138026
Page 85 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)
Sep-11-2020
07:49:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry
:
VITILIGOTranscription
Error
Sep-11-2020
04:36:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Op
enedClarify the
term
VITALIGO as
follows.
Should
spelling be
VITILIGO? If
so, please edit
as such or
clarify further.
Thank you.
Sep-10-2020
13:38:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry
:
VITALIGOInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-10-2020 13:38:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/1978Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020 13:38:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
1.b
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138027
Page 86 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-10-2020 13:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:ASTHMA
Start Date: UNK/UNK/1
951
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 13:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ASTHMAInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020 13:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/1951Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020 13:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
1.c
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138028
Page 87 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-10-2020 13:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:MYOCARDIAL I
NFARCTION
Start Date: Feb/14/2016
Ongoing: NO
End Date:
Feb/14/2016Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138029
Page 88 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 13:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
MYOCARDIAL INFARCTIO
NInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020 13:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Feb/14/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020 13:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NO
End Date:
Feb/14/2016Initial Entry
1.d
Date Location User Value Reason
Sep-10-2020 15:56:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Line/MH
Number:4
Medical Hi
story Term
:STENT CARDI
AC INSERTIO
N
Start Date: Feb/14/2016New Information
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138030
Page 89 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Date:
Feb/14/2016
Sep-10-2020 13:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:STENT CA
RDIAC
Start Date: Feb/14/2016
Ongoing: NO
End Date:
Feb/14/20
16Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138031
Page 90 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 15:56:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
STENT CARDIAC INSERTI
ONNew Information
Sep-10-2020 13:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
STENT CARDIACInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020 13:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Feb/14/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020 13:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NO
End Date:
Feb/14/2016Initial Entry
1.e
Date Location User Value Reason
Sep-10-2020 13:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138032
Page 91 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical Histor
y Term:HYPOTHYRO
IDISM
Start Date: UNK/UNK/20
16
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 13:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
HYPOTHYROIDISMInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-10-2020 13:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-10-2020 13:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-10-2020 13:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:6Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138033
Page 92 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical His
tory Term:CORONARY AR
TERY DISEASE
Start Date: UNK/UNK/2005
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 13:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CORONARY ARTERY DISE
ASEInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-10-2020 13:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-10-2020 13:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138034
Page 93 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10131517 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 13:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 13:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020Transcription Error
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Vital signs Date
10/Feb/2020 is not
same as Date of
Visit 10/Sep/2020.
Please review and
update as
appropriate or
clarify.
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Feb/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
77.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138035
Page 94 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
182.8Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 13:41:51
(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
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.1Initial Entry
7.a
Date Location User Value Reason
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Identifie
r::1
Temperature: 37.0
Temperature U
nit:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138036
Page 95 of 144
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020 13:41:51
(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
Sep-10-2020 13:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138037
Page 96 of 144
***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: 10131517 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
Sep-10-2020 13:42:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 13:42:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
256937Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138038
Page 97 of 144
***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: 10131517 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 13:42:10
(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 13:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 15:34:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 13:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 13:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138039
Page 98 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020 15:34:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BN62J2Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 15:34:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BN62J2Initial Entry
5.b
Date Location User Value Reason
Sep-10-2020 15:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BN62J3Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020 15:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BN62J3Initial Entry
5.c
Date Location User Value Reason
Sep-10-2020 15:34:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BN62J4Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020 15:34:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BN62J4Initial Entry
5.d
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138040
Page 99 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-10-2020 15:34:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BMN4KPInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-10-2020 15:34:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN4KPInitial Entry
5.e
Date Location User Value Reason
Sep-10-2020 15:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BMN4KRInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-10-2020 15:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN4KRInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138041
Page 100 of 144
***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: 10131517 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 13:42:18
(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 13:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 15:35:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 13:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 13:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138042
Page 101 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020 15:35:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BPC2W4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 15:35:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2W4Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138043
Page 102 of 144
***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: 10131517 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 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 13:42:46
(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 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020 13:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138044
Page 103 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 13:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138045
Page 104 of 144
***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: 10131517 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
Sep-10-2020 13:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138046
Page 105 of 144
***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: 10131517 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-30-2020 15:12:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/30/2020Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138047
Page 106 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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-30-2020 15:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020 15:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Record Identifie
r::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 15:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 15:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020 15:13:09
(UTC-05:00) EasternACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
CInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138048
Page 107 of 144
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020 15:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138049
Page 108 of 144
***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: 10131517 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-30-2020 15:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 15:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 17:21:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 15:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-30-2020 15:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138050
Page 109 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-30-2020 17:21:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BRG2PBInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 17:21:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BRG2PBInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138051
Page 110 of 144
***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: 10131517 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-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/30/2020 14:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138052
Page 111 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-30-2020 15:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138053
Page 112 of 144
***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: 10131517 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-28-2020 13:03:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/28/2020Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138054
Page 113 of 144
***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: 10131517 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-28-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020 07:54:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 07:35:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-28-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-28-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138055
Page 114 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct/28/2020
5.a
Date Location User Value Reason
Oct-29-2020 07:54:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BR640MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020 07:54:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BR640MInitial Entry
5.b
Date Location User Value Reason
Oct-29-2020 07:54:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BR640NInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020 07:54:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BR640NInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020 07:54:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BR640PInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138056
Page 115 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-29-2020 07:54:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BR640PInitial Entry
5.d
Date Location User Value Reason
Oct-29-2020 07:54:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BSHPSRInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-29-2020 07:54:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BSHPSRInitial Entry
5.e
Date Location User Value Reason
Oct-29-2020 07:54:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BSHPSSInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-29-2020 07:54:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BSHPSSInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138057
Page 116 of 144
***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: 10131517 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-28-2020 13:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 13:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 13:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138058
Page 117 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Form Created
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138059
Page 118 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Form Created
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138060
Page 119 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Form Created
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138061
Page 120 of 144
***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, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-30-2020 15:18:41
(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
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
INJECTION SITE PAIN TO L
EFT ARMInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/10/2020 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date Time:
Sep/11/2020 08:00Initial Entry
6. Toxicity Grade:
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138062
Page 121 of 144
***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, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-30-2020 15:18:41
(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
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138063
Page 122 of 144
***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, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-30-2020 15:18:41
(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
Sep-30-2020 15:18:41
(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
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-30-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138064
Page 123 of 144
***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, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
FATIGUEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/11/2020 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date Time:
Sep/11/2020 19:00Initial Entry
6. Toxicity Grade:
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138065
Page 124 of 144
***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, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-30-2020 15:21:11
(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
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138066
Page 125 of 144
***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, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-30-2020 15:21:11
(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
Sep-30-2020 15:21:11
(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
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-30-2020 15:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138067
Page 126 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Dec-17-2020
16:42:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Clo
sedResponse
satisfies query
Dec-16-2020
15:48:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew Stephens
(pfe mstephens)Query
3: An
swere
dPER CRC, THE
REPORT THAT
WAS SENT IN
ONLY HAD
STEMI ON IT.
Dec-10-2020
10:20:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Rei
ssued:
Open
edCLINICAL
Thank you,
however
'original value'
is STEMI on AE
CRF and
NSTEMI on
SAE report. The
event must have
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138068
Page 127 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
the same name
in both
locations; please
update in the
appropriate
location.
Dec-08-2020
13:59:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query
3: An
swere
dOriginal value is
correct
Dec-06-2020
11:57:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Op
enedCLINICAL -
SAE reported
event term is
NSTEMI;
however, AE
term and SAE
narrative state
STEMI. Please
review,
harmonize
reporting, and
update in the
appropriate
locations;
include ECG
report if
available.
Dec-02-2020
19:23:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
2: Clo
sedResponse
satisfies query
Dec-02-2020
13:52:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dChanged
Information
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138069
Page 128 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-02-2020
13:52:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew Stephens
(pfe mstephens)Data
Entry
:
STE
MIChanged
Information
Dec-01-2020
18:02:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
2: Op
enedCLINICAL
Event term is
MI; however,
SAE narrative
states ST
elevation was
reported.
Consider
modifying the
event term with
this specific
information (eg
STEMI) on AE
CRF/in SAE
report
Nov-17-2020
14:46:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Gladys Noi (pfe noig) Query
1: Clo
sedResponse
satisfies query
Nov-17-2020
13:58:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew Stephens
(pfe mstephens)Query
1: An
swere
dNOT A
WORSENING
CONDITION
AS
MYOCARDIAL
INFARCTION
HAS A STOP
AND END
DATE. THIS IS
A NEW
SEPERATE
EVENT.
Nov-17-2020
13:22:24
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
1: Op
enedThe AE
MYOCARDIAL
INFARCTION
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138070
Page 129 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US &
Canada)was reported but
is also listed in
Medical History.
Please clarify if
this is a
worsening of the
baseline
condition, and if
so, please
consider adding
"worsening" to
the AE term. AE
as baseline
conditions
should only be
reported as AEs
if they worsen.
"[vathm
SDQ=56236]"
Nov-16-2020
11:19:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data
Entry
:
MYO
CAR
DIAL
INFA
RCTI
ONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/8/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date Time:Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138071
Page 130 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov/10/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-02-2020 19:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 4: Closed Query closed; will
follow for SAE
update with the
requested Con Meds
info
Dec-02-2020 13:53:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 4: Answered CRC WILL
UPDATE
Dec-02-2020 01:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swetha
Thangellapally
(pfe.thangs22)Query 4: Opened CLINICAL -
subject has chronic
med conditions
(CAD, asthma,
hypothyroid) which
suggest chronic
medications are
administered; if so,
please add to SAE
concomitant
Medications section
in a safety update
Dec-01-2020 18:03:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 4: Candidate CLINICAL -
subject has chronic
med conditions
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138072
Page 131 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(CAD, asthma,
hypothyroid) which
suggest chronic
medications are
administered; if so,
please add to SAE
concomitant
Medications section
in a safety update
Dec-01-2020 17:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Nov-30-2020 14:05:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 3: Answered PER CRC THIS
INFORMATION
WAS ALREADY
SUBMITTED.
Nov-19-2020 00:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Opened Clinical COVID test
status (yes/no)
during Hosp was
not reported in the
SAE. Please submit
a follow-up SAE
form
[#2020453470] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Nov-17-2020 05:57:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-16-2020 11:22:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-16-2020 11:22:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Is this serious event associTranscription Error
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138073
Page 132 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
ated with congenital anom
aly or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
YES
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
NO
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE
MYOCARDIAL
INFARCTION:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Is the adverse event
serious?' is marked
as YES, but
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138074
Page 133 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
responses to all of
the seriousness
criteria are NO. At
least one
seriousness criterion
is expected to be
YES for serious
events. Please
review and update
as appropriate.
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
NO
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
NOInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138075
Page 134 of 144
***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: 10131517 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
Nov-16-2020 11:19:43
(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
Dec-06-2020 11:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Dec-04-2020 10:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Dec-04-2020 10:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
OTHER
If Other, specify:
CORONARY ARTER
Y DISEASEChanged
Information
Dec-02-2020 19:26:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Reissued:Opened CLINICAL - Event
(now STEMI)
relationship is
unchanged (related
to itself ie MI)
Dec-02-2020 13:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered Changed data per
query
Dec-01-2020 17:53:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Reissued:Opened CLINICAL This
query refers to AE
CRF (not SAE
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138076
Page 135 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
submission); event
MI cannot be
related to MI.
Subject with past
Med Hx of CAD;
please review &
update relationship
as appropriate.
Nov-30-2020 14:05:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered PER CRD THIS
INFORMATION
WAS ARLEADY
SUBMITTED.
Nov-19-2020 00:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical Event is
reported as related
to itself, rather than
underlying med Hx
of CAD. Please
review and update
if appropriate.
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
OTHER
If Other, specify:
MYOCARDIAL INF
ARCTIONInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 11:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138077
Page 136 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-16-2020 11:19:43
(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
Nov-16-2020 11:19:43
(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
Dec-01-2020 07:12:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed Response satisfies
query
Nov-30-2020 14:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 1: Answered PER CRC THIS
INFORMATION
WAS ALREADY
SUBMITTED.
Nov-19-2020 04:45:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reissued:Opened SAE RECON 2:
Outcome is still
recovering/resolving
in SDB. Per PSSR
confirmation, no
follow up form was
received. Please
submit a follow up
AEM form to update
outcome in Safety
database.
Nov-17-2020 14:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gladys Noi
(pfe.noig)Query 1: Reissued:Candidat
ePending DB update
Nov-17-2020 11:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 1: Answered CORRECT AS
CHARTED.
FOLLOW UP
PENDING.
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138078
Page 137 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-17-2020 10:38:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reissued:Opened SAE RECON 1:
Please confirm if a
follow up AEM form
was submitted
indicating correct
outcome of
recovered/resolved in
SDB
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138079
Page 138 of 144
***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: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-17-2020
08:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 1: Answe
redOriginal value is correct
Nov-17-2020
06:00:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opene
dSAE
RECON:AER#2020453470,outcome
was reported as
RECOVERED/RESOLVED in AE
CRF however,recorded as
Recovering/Resolving in Safety
database. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Nov-16-2020
11:19:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
RECOVERED/
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 11:19:43
(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
Nov-17-2020 05:57:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020453470Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138080
Page 139 of 144
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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
Jan-22-2021 08:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Jan/5/2021Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138081
Page 140 of 144
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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
Jan-19-2021 07:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kimberly
Forbus
(pfe forbuk)Query 2: Closed Response satisfies
query
Jan-18-2021 21:13:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Jan-18-2021 21:13:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible and NOT confirm
ed to have received only p
lacebo at Vaccination 1/2Transcription Error
Jan-16-2021 09:42:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kimberly
Forbus
(pfe forbuk)Query 2: Opened Source reports that
the subject received
BNT162b2. Please
review and update
if required.
Jan-06-2021 15:59:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-06-2021 15:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-06-2021 15:58:51
(UTC-05:00) EasternACV0PFEINFP6000 Matthew
StephensData Entry:
Participant is willing to returInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138082
Page 141 of 144
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe mstephens) n for Vaccination 3
Participant is:
eligible per local/national
recommendations and con
firmed to have received o
nly placebo at Vaccination
1/2
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138083
Page 142 of 144
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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
Jan-06-2021 15:59:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Jan/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-06-2021 15:59:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138084
Page 143 of 144
***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: 10131517 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-28-2020 13:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-10-2020 13:42:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-10-2020 13:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-28-2020 13:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/28/2020Initial Entry
Sep-10-2020 13:42:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
Sep-10-2020 13:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138085
Page 144 of 144
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131517 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-23-2020 14:56:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f65\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138086