125742 S1 M5 CRF c4591001 1013 10131229

Document text

Page 1 of 157
***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: 10131229 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
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137465
Page 2 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137466
Page 3 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131229]
2.Birth Date: /1995
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):ASIAN
6.Racial Designation:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137467
Page 4 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137468
Page 5 of 157
***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: 10131229 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
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137469
Page 6 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137470
Page 7 of 157
***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: 10131229 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:[ATTENTION DEFICIT HYPERACTIVITY DISORDER]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BREAST AUGMENTATION]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OBESITY]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137471
Page 8 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [79.3]
3.Unit: kg
4.Height: [162.6]
5.Unit: cm
6.Body Mass Index: [30.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137472
Page 9 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/19/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137473
Page 10 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [55842]
3.Randomization Group: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137474
Page 11 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BPYX91]
5.bSample ID [BPYX92]
5.cSample ID [BPYX93]
5.dSample ID [BNWHMD]
5.eSample ID [BNWHMF]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137475
Page 12 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BM8S6Z]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137476
Page 13 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/19/2020 09:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137477
Page 14 of 157
***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: 10131229 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
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137478
Page 15 of 157
***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: 10131229 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
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137479
Page 16 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137480
Page 17 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/10/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137481
Page 18 of 157
***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: 10131229 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 [BPC2WL]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137482
Page 19 of 157
***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: 10131229 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 14:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137483
Page 20 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137484
Page 21 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9TRR]
5.bSample ID [BR9TRS]
5.cSample ID [BR9TRT]
5.dSample ID [BMN58G]
5.eSample ID [BMN58H]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137485
Page 22 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137486
Page 23 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137487
Page 24 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137488
Page 25 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137489
Page 26 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137490
Page 27 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137491
Page 28 of 157
***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: 10131229 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:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137492
Page 29 of 157
***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: 10131229 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: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137493
Page 30 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137494
Page 31 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137495
Page 32 of 157
***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: 10131229 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?
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137496
Page 33 of 157
***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: 10131229 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:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137497
Page 34 of 157
***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: 10131229 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:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137498
Page 35 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137499
Page 36 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137500
Page 37 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137501
Page 38 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137502
Page 39 of 157
***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: 10131229 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: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137503
Page 40 of 157
***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: 10131229 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:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137504
Page 41 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137505
Page 42 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Exposure Durin
g Pregnancy Dec/10/2020
UNK:UNK YES  Repeating
Pages
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137506
Page 43 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Exposure During Pregnancy]
4.Start Date Time: Dec/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137507
Page 44 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[PREGNANCY]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137508
Page 45 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137509
Page 46 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137510
Page 47 of 157
***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: 10131229 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[ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137511
Page 48 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137512
Page 49 of 157
***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: 10131229 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: //
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137513
Page 50 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137514
Page 51 of 157
***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: 10131229 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?
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137515
Page 52 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137516
Page 53 of 157
***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: 10131229 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?
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137517
Page 54 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137518
Page 55 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137519
Page 56 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137520
Page 57 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137521
Page 58 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137522
Page 59 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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?
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137523
Page 60 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137524
Page 61 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137525
Page 62 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137526
Page 63 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137527
Page 64 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137528
Page 65 of 157
***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: 10131229 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 [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137529
Page 66 of 157
***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: 10131229 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/19/2021
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137530
Page 67 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137531
Page 68 of 157
***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: 10131229 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/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137532
Page 69 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137533
Page 70 of 157
***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: 10131229 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: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137534
Page 71 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137535
Page 72 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137536
Page 73 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137537
Page 74 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137538
Page 75 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137539
Page 76 of 157
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137540
Page 77 of 157
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Mar-04-2021 07:15:53 (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.
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137541
Page 78 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-19-2020 14:11:02
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137542
Page 79 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Feb-01-2021 11:50:09 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137543
Page 80 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Mar-04-2021 07:15:53 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Mar-02-2021 16:32:20 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-02-2021 10:45:21 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137544
Page 81 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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.
Monica
Cooper N/A Feb-01-2021 11:49:57 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-01-2021 09:49:25 (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.
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137545
Page 82 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Scott
Salmon N/A Jan-28-2021 19:52:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Jan-22-2021 06:41:41 (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-20-2021 13:42:51 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Oct-21-2020 12:22:53 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137546
Page 83 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Oct-14-2020 14:42:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Oct-05-2020 13:02:31 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137547
Page 84 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-19-2020
14:10:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020
14:10:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137548
Page 85 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020
14:10:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/19/2020Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137549
Page 86 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020
14:10:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10131229Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1995Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020
14:10:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137550
Page 87 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-19-2020
14:10:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020
14:10:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ASIANInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137551
Page 88 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020
14:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/19/2020Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137552
Page 89 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-19-2020
14:11:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020
14:11:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020
14:11:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137553
Page 90 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020
14:11:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:1
Medic
al Hist
ory Te
rm:ATTENTION
DEFICIT HY
PERACTIVIT
Y DISORDE
R
Start
Date:UNK/UNK/20
10
Ongoi
ng:YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-19-2020
14:11:42
(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
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137554
Page 91 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-19-2020
14:11:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ATTENTION DEFI
CIT HYPERACTI
VITY DISORDERInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-19-2020
14:11:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-19-2020
14:11:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-19-2020
14:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:2Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137555
Page 92 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical
History
Term:BREAST A
UGMENTA
TION
Start Da
te:Jun/UNK/20
20
Ongoing
:NO
End Date:
Jun/UNK
/2020
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137556
Page 93 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Aug-19-2020
14:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020
14:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BREAST AUGME
NTATIONInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-19-2020
14:12:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Jun/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-19-2020
14:12:01ACV0PFEINFP6000  Matthew
StephensData Entry:
NOInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137557
Page 94 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) End Date:
Jun/UNK/2020
1.c
Date Location User Value Reason
Aug-19-2020
14:12:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:OBESIT
Y
Start Date: UNK/U
NK/201
6
Ongoing: YESInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137558
Page 95 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Aug-19-2020
14:12:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020
14:12:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
OBESITYInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-19-2020
14:12:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-19-2020
14:12:11ACV0PFEINFP6000  Matthew
StephensData Entry:
YESInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137559
Page 96 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens)
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137560
Page 97 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
79.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137561
Page 98 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
162.6Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
7.a
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:37.1Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137562
Page 99 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137563
Page 100 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020
14:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137564
Page 101 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137565
Page 102 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137566
Page 103 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-19-2020
14:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137567
Page 104 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020
14:13:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020
14:13:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
55842Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137568
Page 105 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020
14:13:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020
14:13:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020
17:56:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-19-2020
14:13:13
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137569
Page 106 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-19-2020
14:13:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020
17:56:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPYX9
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020
17:56:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPYX91Initial Entry
5.b
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137570
Page 107 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-19-2020
17:56:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPYX9
2Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020
17:56:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPYX92Initial Entry
5.c
Date Location User Value Reason
Aug-19-2020
17:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPYX9
3Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137571
Page 108 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Aug-19-2020
17:56:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPYX93Initial Entry
5.d
Date Location User Value Reason
Aug-19-2020
17:56:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample
ID:BNWH
MDInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-19-2020
17:56:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BNWHMDInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020
17:56:33ACV0PFEINFP6000  Matthew
StephensData Entry:
Sample I BNWHInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137572
Page 109 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: MF
5.e Sample ID
Date Location User Value Reason
Aug-19-2020
17:56:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BNWHMFInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137573
Page 110 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020
14:13:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020
14:13:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020
17:56:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-19-2020
14:13:19
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137574
Page 111 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-19-2020
14:13:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020
17:56:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BM8S6
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020
17:56:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8S6ZInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137575
Page 112 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137576
Page 113 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/19/2020 09:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137577
Page 114 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-19-2020
14:13:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137578
Page 115 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-20-2020
10:21:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NO - REACTOG
ENICITY E-DIA
RY NOT COLLE
CTED FOR THIS
SUBJECTTranscription
Error
Aug-19-2020
14:13:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES - REACTOG
ENICITY E-DIA
RY COLLECTED
FOR THIS SUBJ
ECTInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137579
Page 116 of 157
***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: 10131229 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
15:59:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137580
Page 117 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 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
15:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020
15:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:37.1
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
15:59:52
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137581
Page 118 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-10-2020
15:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020
15:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
15:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137582
Page 119 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137583
Page 120 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137584
Page 121 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020
16:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137585
Page 122 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
16:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
16:00:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
17:05:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
16:00:13
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137586
Page 123 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-10-2020
16:00:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
17:05:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2W
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
17:05:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2WLInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137587
Page 124 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020
16:00:25
(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
16:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
16:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137588
Page 125 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-10-2020
16:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/10/2020 14:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
16:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020
16:00:25
(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
16:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137589
Page 126 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020
16:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-10-2020
16:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137590
Page 127 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
14:42:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/14/2020Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137591
Page 128 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
14:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
14:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
08:17:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-15-2020
04:44:55
(UTC-05:00)ACV0PFEINFP6000  Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137592
Page 129 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
14:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
14:42:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
08:17:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TR
RInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137593
Page 130 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-15-2020
08:17:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TRRInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020
08:17:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TR
SInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
08:17:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TRSInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020
08:17:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TR
TInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137594
Page 131 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
08:17:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TRTInitial Entry
5.d
Date Location User Value Reason
Oct-15-2020
08:17:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BMN58
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-15-2020
08:17:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN58GInitial Entry
5.e
Date Location User Value Reason
Oct-15-2020
08:17:42ACV0PFEINFP6000  Matthew
StephensData Entry:
Sample I BMN58Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137595
Page 132 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: H
5.e Sample ID
Date Location User Value Reason
Oct-15-2020
08:17:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN58HInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137596
Page 133 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020
14:42:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
14:42:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
14:42:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137597
Page 134 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Form Created
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137598
Page 135 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-28-2021
19:52:55
(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
Mar-04-2021
11:34:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-25-2021
11:01:05
(UTC-05:00)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answere
dCORRECT AS
CHARTED
AND WAS
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137599
Page 136 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)SUBMITTED.
Feb-23-2021
15:58:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Query closed;
will follow for
requested
miscarriage
history year
information.
Feb-23-2021
15:57:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Query closed;
will follow for
requested Father
information.
Feb-18-2021
18:36:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued
:OpenedClinical - no
further records
required to
match the SAE
with the AE;
please submit
correct term per
Pregnancy
reporting
instructions
'Exposure
during
Pregnancy' to
the PG Safety
report as well
Feb-17-2021
15:03:47
(UTC-05:00)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 3: Answere
dCRC is still
attempting to
contact subject
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137600
Page 137 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)for additional
details.
Feb-17-2021
15:03:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 2: Answere
dCRC still
attempting to
contact subject
for additional
details.
Feb-17-2021
15:02:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answere
dCRC is still
trying to contact
subject for
additional
details.
Feb-17-2021
09:13:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued
:OpenedClinical As of
17Feb21, the
most recent
safety update
was the
08Feb21
submission;
year of prior
delivery still
remains missing
on PG safety
report
Feb-17-2021
09:07:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Reissued
:OpenedClinical As of
17Feb21, the
most recent
safety update
was the
08Feb21
submission; no
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137601
Page 138 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
father info still
on PG safety
report other
than takes MVI
Feb-17-2021
09:06:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued
:OpenedClinical As of
17Feb21, the
most recent
safety update
was the
08Feb21
submission;
pregnancy is
still the event
term on PG
safety report
Feb-11-2021
16:13:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 3: Answere
dUPDATED BY
CRC
Feb-11-2021
16:12:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 2: Answere
dUPDATED BY
CRC
Feb-11-2021
16:10:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answere
dUPDATE
SUBMITTED
BY CRC
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137602
Page 139 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-09-2021
02:00:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical Thank
you; however
PG safety
update (08Feb)
did not report
Father
information
Feb-09-2021
01:59:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued
:OpenedCLINICAL
Thank you; PG
safety update
(08Feb) did not
report year of
subject's prior
pregnancy, and
if the outcome
was miscarriage
(in Med Hx)
Feb-09-2021
01:55:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued
:OpenedClinical Thank
you; however
safety update
(08Feb21)
continues with
event term
'Pregnancy'.
Please submit a
PG safety
update reporting
the modified
event term EDP
Feb-01-2021
11:50:56
(UTC-05:00)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Query 2: Answere
dSafety update
has been
submitted by
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137603
Page 140 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)CRC
Feb-01-2021
11:50:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Query 1: Answere
dSafety update
has been
submitted by
CRC
Jan-29-2021
13:23:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical Please
submit a safety
update
(#2021058335)
with the year for
subject's
previous
miscarriage and
Father info (age,
meds, social hx)
on the
Pregnancy form
Jan-29-2021
13:22:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Event term is
Exposure during
Pregnancy;
however, event
term in Safety
report is
Pregnancy.
Please submit a
Safety update to
report the full
term 'Exposure
during
Pregnancy'
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137604
Page 141 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-29-2021
10:53:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Data Entry:
Exposure During
Pregnancychanged
information per
email query
instructions
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
PREGNANCYInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021
00:17:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-25-2021
11:06:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answere
dPER CRC;
CORRECT AS
IT IS THE
SAME ON AE
AND SAE
FORMS
SUBMITTED.
Feb-23-2021
15:56:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued
:OpenedClinical - the
correct date is
desired for both
AE and PG
safety report, &
must be the
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137605
Page 142 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
same in both
locations.
Please report
either 10Dec20
or ??Dec20 in
both locations
Feb-17-2021
14:59:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answere
dCorrect as
charted per
CRC.
Feb-17-2021
09:08:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued
:OpenedClinical As of
17Feb21, the
most recent
safety update
was the
08Feb21
submission;
start date still
remains
??Dec20 on PG
safety report
Feb-11-2021
16:11:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answere
dUPDATE
SUBMITTED
BY CRC
Feb-09-2021
02:01:56
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued
:OpenedClinical Thank
you; start date
of 10Dec20 is
Estimated date
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137606
Page 143 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US & Canada) of Conception;
however, most
recent PG
safety report
still has
??Dec20
Feb-01-2021
12:04:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Query 1: Answere
dcorrect as
recorded;
Safety update
has been
submitted by
CRC
Jan-29-2021
13:26:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Event
start date is
10Dec20
(estimated date
of conception);
however, safety
report for
pregnancy has
start date of
??Dec20. Please
submit a safety
update to report
the full start
date
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Dec/10/2020 UN
K:UNKInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137607
Page 144 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
11:38:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Clos
edResponse satisfies
query
Feb-25-2021
11:02:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Ans
weredPER CRC, FORMS
ARE BEING
SUBMITTED
25/FEB/2021.
Feb-18-2021
18:37:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reiss
ued:OpenedClinical Please report
Subject's statement
as to whether she is
still pregnant or has
experienced a
miscarriage
(information from
subject does not
require medical
records)
Feb-17-2021
15:04:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Ans
weredCRC is still
attempting to contact
subject for additional
details.
Feb-17-2021
09:12:10
(UTC-05:00)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reiss
ued:OpenedClinical As of
17Feb21, the most
recent safety update
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137608
Page 145 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)was the 08Feb21
submission (current
status is Ongoing).
Please clarify in
query response - was
there a miscarriage?
If so, please record
this pregnancy
adverse outcome on
AE CRF
Feb-11-2021
16:11:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Ans
weredUPDATED FORMS
PER CRC
Feb-09-2021
02:06:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Open
edClinical - Current
status is Ongoing/no
stop date; however,
recent PG safety
update reported
'outcome of
spontaneous
abortion/miscarriage'.
If a PG adverse
outcome has
occurred, please
record it on the AE
CRF
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137609
Page 146 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US & Canada)
6. Toxicity Grade:
Date Location User Value Reason
Feb-02-2021
09:58:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-01-2021
11:50:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
Feb-01-2021
11:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Feb-01-2021
11:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Data Entry: Transcription
Error
Jan-29-2021
13:20:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical As per
CRF CG
8.50.2.5, the
toxicity grade
for “Exposure
During
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137610
Page 147 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Pregnancy” is
reported as Not
Applicable
Jan-28-2021
19:52:55
(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
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137611
Page 148 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-28-2021
19:52:55
(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
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
PREGNANCYInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-28-2021
19:52:55ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137612
Page 149 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-28-2021
19:52:55
(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
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
RECOVERING/RE
SOLVINGInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137613
Page 150 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-28-2021
19:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137614
Page 151 of 157
***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: 10131229 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-20-2021
13:43:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Jan/19/2021Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137615
Page 152 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-03-2021
06:25:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Ajit Malode
(pfe.maloda)Query 1: Closed Site has
updated the
response to
'have received
only placebo at
Vaccination
1/2 '.
Mar-02-2021
16:32:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Mar-02-2021
16:32:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have receive
d only placebo
at Vaccination
1/2Transcription
Error
Mar-02-2021
09:55:02ACV0PFEINFP6000  Pratiksha
MahadikQuery 1: Opened DM:
Participant is
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137616
Page 153 of 157
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)(pfe.mahadp07) eligible and
confirmed to
have received
Placebo on the
Further
Vaccination
Confirmation
CRF, However
Date Written
Consent
Obtained is
missing in
InFormed
Consent -
Further
Vaccination
CRF. Kindly
review and
update, else
clarify.
Jan-20-2021
13:43:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loc
al/national reco
mmendations a
nd confirmed t
o have receive
d only placebo
at Vaccination
1/2Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137617
Page 154 of 157
***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: 10131229 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-20-2021
13:42:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-20-2021
13:42:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137618
Page 155 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020
14:42:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020
14:13:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-19-2020
14:11:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-02-2021
18:33:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Jan-28-2021
19:48:09ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answered UPDATED
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137619
Page 156 of 157
***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: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
Jan-25-2021
11:46:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical
Please enter
the event
'Pregnancy' on
the AE CRF
Oct-14-2020
14:42:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Aug-19-2020
14:13:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
Aug-19-2020
14:11:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137620
Page 157 of 157
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131229 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-15-2020
10:36:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f59\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0137621