125742 S1 M5 CRF c4591001 1013 10131718

Document text

Page 1 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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 version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139435
Page 2 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/14/2020
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139436
Page 3 of 428
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131718]
2.Birth Date: /1967
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):AMERICAN INDIAN OR ALASKA NATIVE
WHITE
6.Racial Designation:
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0139437
Page 4 of 428
***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: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139438
Page 5 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139439
Page 6 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139440
Page 7 of 428
***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: 10131718 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:[PARTIAL HYSTERECTOMY]
Start Date: Feb/UNK/2017
Ongoing: NO
End Date:
Feb/UNK/2017
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ALLERGIC TO SULFA]
Start Date: UNK/UNK/1993
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ANXIETY DISORDER]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139441
Page 8 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139442
Page 9 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
2.Weight: [85.85]
3.Unit: kg
4.Height: [165.2]
5.Unit: cm
6.Body Mass Index: [31.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139443
Page 10 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139444
Page 11 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/14/2020
2.Randomization Number: [107472]
3.Randomization Group: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139445
Page 12 of 428
***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: 10131718 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 [BSJTDN]
5.bSample ID [BSJTDP]
5.cSample ID [BRD791]
5.dSample ID [BRD792]
5.eSample ID [BRD793]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139446
Page 13 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/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 [BR9TD0]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139447
Page 14 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/14/2020 11:03
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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139448
Page 15 of 428
***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: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139449
Page 16 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139450
Page 17 of 428
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139451
Page 18 of 428
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139452
Page 19 of 428
***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: 10131718 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:
Nov/2/2020
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 [BR9TL0]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139453
Page 20 of 428
***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: 10131718 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: Nov/2/2020 16:08
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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139454
Page 21 of 428
***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: 10131718 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 Dec/3/2020
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139455
Page 22 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139456
Page 23 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139457
Page 24 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/5/2020
2.Date of First Symptom
Started:Nov/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/4/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139458
Page 25 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139459
Page 26 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice T
ypeForm Instan
ce
 1.Not Applic
able Not Appli
cable Not Applicable  Not Applicable  Not Appli
cable Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139460
Page 27 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and
Description:Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings
/Details:Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139461
Page 28 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 10131718 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_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[SWAB COLLECTED IN OFFICE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139462
Page 29 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
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: 10131718 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:
Nov/5/2020
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 [BR9TMC]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139463
Page 30 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139464
Page 31 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139465
Page 32 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
 1.Not Applicab
le Not Applicable  Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139466
Page 33 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139467
Page 34 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139468
Page 35 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139469
Page 36 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139470
Page 37 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
y for La
b TestVendor NameColle
ction
Date
:Spec
imen
TypeLab ResultForm Inst
ance
 1.CLINIC
AL CH
EMIST
RY ORLANDO REGIONA
L MEDICAL CENTER,
1414 KUHL AVE. ORL
ANDO, FL 32806 Nov/
5/202
0 BLO
OD Sponso
r-Defin
ed Iden
tifierTest:Re
sul
t:
329  C Reactiv
e Protein_
PX329 1.4
 
30  Alanine A
minotrans
ferase_PX
30 25 
28  Aspartate
Aminotra
nsferase_
PX28 18 
35  Alkaline
Phosphata
se_PX35 65 
21  Bilirubin_
PX21 0.5
 
47  Blood Ur
ea Nitrog
en_PX47 12 
48  Creatinine
_PX48 0.8
1 Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139471
Page 38 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
y for La
b TestVendor NameColle
ction
Date
:Spec
imen
TypeLab ResultForm Inst
ance
 2.CLINIC
AL CH
EMIST
RY ORLANDO REGIONA
L MEDICAL CENTER,
1414 KUHL AVE. ORL
ANDO, FL 32806 Dec/
3/202
0 BLO
OD Sponso
r-Defin
ed Iden
tifierTest:Re
sul
t:
329  C Reactiv
e Protein_
PX329 2.2
 
30  Alanine A
minotrans
ferase_PX
30 19 
28  Aspartate
Aminotra
nsferase_
PX28 15 
35  Alkaline
Phosphata
se_PX35 70 
21  Bilirubin_
PX21 0.5
 
47  Blood Ur
ea Nitrog
en_PX47 11 
48  Creatinine
_PX48 0.8
0 Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139472
Page 39 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[ORLANDO REGIONAL MEDICAL CENTER, 1414 KUHL
AVE. ORLANDO, FL 32806]
3.Collection Date: Nov/5/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.4]
Not Done:
LNMT Low
[ ]
High
[9.9]
Unit
mg/L
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139473
Page 40 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [25]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [18]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139474
Page 41 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [65]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139475
Page 42 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [12]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.81]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139476
Page 43 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[ORLANDO REGIONAL MEDICAL CENTER, 1414 KUHL
AVE. ORLANDO, FL 32806]
3.Collection Date: Dec/3/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [2.2]
Not Done:
LNMT Low
[ ]
High
[9.9]
Unit
mg/L
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139477
Page 44 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [19]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [15]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139478
Page 45 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [70]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139479
Page 46 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [11]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.80]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139480
Page 47 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ry for
Lab Te
stVendor Name (DERIVE
D)Colle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
 1.HEMA
TOLO
GY ORLANDO REGIONAL
MEDICAL CENTER, 141
4 KUHL AVE. ORLAND
O, FL 32806 Nov/
5/202
0 BLO
OD Sponsor
-Define
d Identi
fierTest:Re
sul
t:
1  Hemog
lobin_
PX1 13.
8 
2  Hemat
ocrit_P
X2 48.
3 
3  Erythro
cytes_
PX3 4.5
5 
5  Platelet
s_PX5 20
9 
7  Leukoc
ytes_P
X7 5.5
 
608  Neutro
phils_P
X608 3.6
 
609  Eosino
phils_P
X609 0.2
 Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139481
Page 48 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ry for
Lab Te
stVendor Name (DERIVE
D)Colle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
Sponsor
-Define
d Identi
fierTest:Re
sul
t:
612  Monoc
ytes_P
X612 0.3
 
610  Basoph
ils_PX
610 0.0
 
611  Lymph
ocytes_
PX611 1.5
 
 2.HEMA
TOLO
GY ORLANDO REGIONAL
MEDICAL CENTER, 141
4 KUHL AVE. ORLAND
O, FL 32806 Dec/3
/2020
 BLO
OD Sponsor
-Define
d Identi
fierTest:Re
sul
t:
1  Hemog
lobin_
PX1 14.
2 
2  Hemat
ocrit_P
X2 44.
7 
3  Erythro
cytes_4.5
5 Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139482
Page 49 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ry for
Lab Te
stVendor Name (DERIVE
D)Colle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
Sponsor
-Define
d Identi
fierTest:Re
sul
t:
PX3 
5  Platelet
s_PX5 22
3 
7  Leukoc
ytes_P
X7 5.6
 
608  Neutro
phils_P
X608 3.5
 
609  Eosino
phils_P
X609 0.1
 
612  Monoc
ytes_P
X612 0.3
 
610  Basoph
ils_PX
610 0.0
 
611  Lymph
ocytes_
PX611 1.7
 
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139483
Page 50 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[ORLANDO REGIONAL MEDICAL CENTER, 1414 KUHL
AVE. ORLANDO, FL 32806]
3.Collection Date: Nov/5/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.8]
Not Done:
LNMT Low
[11.4]
High
[14.7]
Unit
g/dL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139484
Page 51 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [48.3]
Not Done:
LNMT Low
[34.3]
High
[45.5]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.55]
Not Done:
LNMT Low
[3.75]
High
[5.00]
Unit
10^6/cu mm
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139485
Page 52 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [209]
Not Done:
LNMT Low
[139]
High
[361]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.5]
Not Done:
LNMT Low
[4.4]
High
[10.5]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139486
Page 53 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.6]
Not Done:
LNMT Low
[1.5]
High
[7.5]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.2]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139487
Page 54 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139488
Page 55 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.5]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139489
Page 56 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[ORLANDO REGIONAL MEDICAL CENTER, 1414 KUHL
AVE. ORLANDO, FL 32806]
3.Collection Date: Dec/3/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.2]
Not Done:
LNMT Low
[11.4]
High
[14.7]
Unit
g/dL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139490
Page 57 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [44.7]
Not Done:
LNMT Low
[34.3]
High
[45.5]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.55]
Not Done:
LNMT Low
[3.75]
High
[5.00]
Unit
10^6/cu mm
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139491
Page 58 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [223]
Not Done:
LNMT Low
[139]
High
[361]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.6]
Not Done:
LNMT Low
[4.4]
High
[10.5]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139492
Page 59 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.5]
Not Done:
LNMT Low
[1.5]
High
[7.5]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139493
Page 60 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139494
Page 61 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.7]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139495
Page 62 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
 1.Nov/5/2020 Record Identifier: Systolic: Diastolic:
1  120  82 Repeating Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139496
Page 63 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in
beats/minute:[70]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139497
Page 64 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
 1.Nov/5/2020 Record Identifier: Oxygen Saturation
1  94.0 Repeating Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139498
Page 65 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139499
Page 66 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139500
Page 67 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139501
Page 68 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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
nStart D
ateForm Instan
ce
 1.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139502
Page 69 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139503
Page 70 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.Not Applicable  Not Applicable  Not Applicabl
e Not Applicable  Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139504
Page 71 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139505
Page 72 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/03/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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 Dec/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139506
Page 73 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 10131718 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:
Dec/3/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRHWDV]
5.bSample ID [BRHWDW]
5.cSample ID [BRHWDX]
5.dSample ID [BS37ZC]
5.eSample ID [BS37ZD]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139507
Page 74 of 428
***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: 10131718 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:
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139508
Page 75 of 428
***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: 10131718 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 [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139509
Page 76 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  FATIGUE
 Nov/4/2020
11:00 NO
End Date Time:
Nov/5/2020 22:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  CHILLS  Nov/4/2020
11:00 NO
End Date Time:
Nov/5/2020 22:00
 Repeating
Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139510
Page 77 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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)[FATIGUE]
4.Start Date Time: Nov/4/2020 11:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/5/2020 22:00
6.Toxicity Grade: 1
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139511
Page 78 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139512
Page 79 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139513
Page 80 of 428
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[CHILLS]
4.Start Date Time: Nov/4/2020 11:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/5/2020 22:00
6.Toxicity Grade: 1
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139514
Page 81 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
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Page 82 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
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FDA-CBER-2021-5683-0139516
Page 83 of 428
***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: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139517
Page 84 of 428
***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: 10131718 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[ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139518
Page 85 of 428
***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: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139519
Page 86 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
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***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: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139521
Page 88 of 428
***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: 10131718 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?
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139522
Page 89 of 428
***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: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139523
Page 90 of 428
***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: 10131718 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?
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139524
Page 91 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139525
Page 92 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139526
Page 93 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139527
Page 94 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139528
Page 95 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139529
Page 96 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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FDA-CBER-2021-5683-0139530
Page 97 of 428
***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: 10131718 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:
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FDA-CBER-2021-5683-0139531
Page 98 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
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FDA-CBER-2021-5683-0139532
Page 99 of 428
***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: 10131718 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: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139533
Page 100 of 428
***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: 10131718 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: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139534
Page 101 of 428
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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 :Dec/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139535
Page 102 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139536
Page 103 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139537
Page 104 of 428
***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: 10131718 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: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139538
Page 105 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139539
Page 106 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139540
Page 107 of 428
***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: 10131718 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: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139541
Page 108 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139542
Page 109 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/24/2021
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139543
Page 110 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139544
Page 111 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/24/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139545
Page 112 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139546
Page 113 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS49CJ]
5.bSample ID [BS49CK]
5.cSample ID [BV09WK]
5.dSample ID [BV09WL]
5.eSample ID [BV09WM]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139547
Page 114 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR64HG]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139548
Page 115 of 428
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/24/2021 15:53
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139549
Page 116 of 428
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139550
Page 117 of 428
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139551
Page 118 of 428
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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 [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139552
Page 119 of 428
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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?
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139553
Page 120 of 428
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139554
Page 121 of 428
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139555
Page 122 of 428
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139556
Page 123 of 428
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139557
Page 124 of 428
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139558
Page 125 of 428
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139559
Page 126 of 428
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139560
Page 127 of 428
***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: 10131718 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 Dec/3/2020
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139561
Page 128 of 428
***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: 10131718 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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139562
Page 129 of 428
***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: 10131718 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 08:06:12 (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.
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139563
Page 130 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-14-2020 17:05:44 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139564
Page 131 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139565
Page 132 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Oct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139566
Page 133 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Oct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139567
Page 134 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Oct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139568
Page 135 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Oct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139569
Page 136 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Oct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139570
Page 137 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139571
Page 138 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139572
Page 139 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-14-2020 17:12:13 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139573
Page 140 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139574
Page 141 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139575
Page 142 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139576
Page 143 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139577
Page 144 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139578
Page 145 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Nov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139579
Page 146 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139580
Page 147 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139581
Page 148 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-02-2020 16:48:04 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139582
Page 149 of 428
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-06-2020 08:20:26
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)NOT APPLICABLE
Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139583
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Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-06-2020 08:20:26 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)NOT APPLICABLE
Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139584
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***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-06-2020 08:20:26 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)NOT APPLICABLE
Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139585
Page 152 of 428
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-06-2020 08:20:26 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)NOT APPLICABLE
Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139586
Page 153 of 428
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-06-2020 08:20:26 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)NOT APPLICABLE
Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139587
Page 154 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139588
Page 155 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139589
Page 156 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139590
Page 157 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139591
Page 158 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139592
Page 159 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139593
Page 160 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139594
Page 161 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139595
Page 162 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139596
Page 163 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Nov-05-2020 17:01:57 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139597
Page 164 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-05-2020 17:03:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139598
Page 165 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-05-2020 17:03:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139599
Page 166 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-05-2020 17:03:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139600
Page 167 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-05-2020 17:03:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139601
Page 168 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-05-2020 17:03:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139602
Page 169 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Nov-05-2020 17:03:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139603
Page 170 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Nov-05-2020 17:03:07 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139604
Page 171 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-05-2020 17:04:02 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139605
Page 172 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-05-2020 17:04:02 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139606
Page 173 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-05-2020 17:04:02 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139607
Page 174 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-05-2020 17:04:02 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139608
Page 175 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-05-2020 17:04:02 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139609
Page 176 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-05-2020 17:06:05 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139610
Page 177 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-05-2020 17:06:05 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139611
Page 178 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-05-2020 17:06:05 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139612
Page 179 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-05-2020 17:06:05 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139613
Page 180 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-05-2020 17:06:34 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139614
Page 181 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-05-2020 17:06:34 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139615
Page 182 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-05-2020 17:06:34 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139616
Page 183 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-05-2020 17:06:34 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139617
Page 184 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-05-2020 17:06:34 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139618
Page 185 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Nov-05-2020 17:06:34 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139619
Page 186 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Nov-05-2020 17:06:34 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139620
Page 187 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-05-2020 17:06:58 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139621
Page 188 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-05-2020 17:06:58 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139622
Page 189 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-05-2020 17:06:58 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139623
Page 190 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-05-2020 17:06:58 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139624
Page 191 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-05-2020 17:06:58 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139625
Page 192 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-25-2021 13:29:30 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139626
Page 193 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139627
Page 194 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139628
Page 195 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139629
Page 196 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139630
Page 197 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139631
Page 198 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Feb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139632
Page 199 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139633
Page 200 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139634
Page 201 of 428
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-25-2021 13:30:18 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139635
Page 202 of 428
***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: 10131718 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 08:06:12 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Feb-25-2021 15:03:41 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Brown Approved Feb-25-2021 14:46:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139636
Page 203 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, PatriciaBrown, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139637
Page 204 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-14-2020
17:02:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-14-2020
17:02:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139638
Page 205 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020
17:03:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Oct/14/2020Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139639
Page 206 of 428
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020
17:02:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10131718Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020
17:02:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1967Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020
17:05:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0139640
Page 207 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-14-2020
17:05:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020
17:05:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
AMERICAN INDIA
N OR ALASKA NA
TIVE
WHITEInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139641
Page 208 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
17:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/14/2020Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139642
Page 209 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-14-2020
17:06:26
(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
17:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
17:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139643
Page 210 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020
17:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:1
Medical
History
Term:PARTIAL H
YSTERECT
OMY
Start Da
te:Feb/UNK/20
17
Ongoing
:NO
End Date:
Feb/UNK
/2017Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020
17:08:01
(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
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139644
Page 211 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-14-2020
17:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
PARTIAL HYSTER
ECTOMYInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-14-2020
17:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-14-2020
17:08:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date:
Feb/UNK/2017Initial Entry
1.b
Date Location User Value Reason
Oct-14-2020
17:08:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139645
Page 212 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical H
istory Ter
m:ALLERGI
C TO SUL
FA
Start Date
:UNK/UN
K/1993
Ongoing: YES
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139646
Page 213 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020
17:08:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020
17:08:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ALLERGIC TO SUL
FAInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-14-2020
17:08:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
UNK/UNK/1993Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020
17:08:38ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139647
Page 214 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Oct-14-2020
17:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:ANXIET
Y DISOR
DER
Start Date
:UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139648
Page 215 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Oct-14-2020
17:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020
17:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ANXIETY DISORD
ERInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-14-2020
17:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-14-2020
17:09:37ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139649
Page 216 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139650
Page 217 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-14-2020
17:09:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
The subject is NOT k
nown to be HIV POS
ITIVEInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139651
Page 218 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
85.85Initial Entry
3. Unit:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139652
Page 219 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
165.2Initial Entry
5. Unit:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.5Initial Entry
7.a
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.0Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139653
Page 220 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
CInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139654
Page 221 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Oct-14-2020
17:10:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139655
Page 222 of 428
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-20-2020
20:38:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hui Pan
(pfe.panh18)Query 1: Closed Response satisfies
query
Oct-19-2020
08:48:27
(UTC-05:00)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Query 1: Answe
redPARTIAL
HYSTERECTOMY
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139656
Page 223 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)
Oct-15-2020
21:11:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hui Pan
(pfe.panh18)Query 1: Opene
dClinQuery: V1:
Please can you
confirm why a
pregnancy test was
not done for ths
subject? There is
nothing in her
medhx to indicate
she is not a woman
of child bearing
potential. Update
MedHx as
appropriate. Thanks
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139657
Page 224 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139658
Page 225 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
6.a Test:
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-14-2020
17:12:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139659
Page 226 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-14-2020
17:12:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-14-2020
17:12:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
107472Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139660
Page 227 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
17:08:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
17:08:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
17:08:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
17:08:31
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139661
Page 228 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
17:08:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
17:08:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BSJTD
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
17:08:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BSJTDNInitial Entry
5.b
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139662
Page 229 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-14-2020
17:08:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BSJTD
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
17:08:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BSJTDPInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020
17:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRD79
1Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139663
Page 230 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
17:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRD791Initial Entry
5.d
Date Location User Value Reason
Oct-14-2020
17:09:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRD79
2Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-14-2020
17:09:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRD792Initial Entry
5.e
Date Location User Value Reason
Oct-14-2020
17:09:28ACV0PFEINFP6000  Matthew
StephensData Entry:
Sample I BRD79Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139664
Page 231 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: 3
5.e Sample ID
Date Location User Value Reason
Oct-14-2020
17:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRD793Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139665
Page 232 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
17:07:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
17:07:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
17:08:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
17:07:58
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139666
Page 233 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
17:07:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
17:08:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TD
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
17:08:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TD0Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139667
Page 234 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139668
Page 235 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/14/2020 11:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139669
Page 236 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-14-2020
17:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139670
Page 237 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-14-2020
17:13:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139671
Page 238 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020
16:45:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/2/2020Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139672
Page 239 of 428
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Nov-02-2020
16:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/2/2020Initial Entry
2.a
Date Location User Value Reason
Nov-02-2020
16:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.8
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-02-2020
16:45:25
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
1Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139673
Page 240 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Nov-02-2020
16:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-02-2020
16:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-02-2020
16:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139674
Page 241 of 428
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 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
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139675
Page 242 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139676
Page 243 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
6.a Sponsor ID:
Date Location User Value Reason
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Nov-02-2020
16:48:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-02-2020
16:48:04ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139677
Page 244 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139678
Page 245 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020
16:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020
16:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020
16:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-02-2020
16:48:27
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139679
Page 246 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-02-2020
16:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020
16:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR9TL
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020
16:59:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BR9TL0Initial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139680
Page 247 of 428
***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: 10131718 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
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139681
Page 248 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/2/2020 16:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139682
Page 249 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-02-2020
16:48:57
(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
Nov-02-2020
16:48:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139683
Page 250 of 428
***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: 10131718 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
Dec-07-2020
08:23:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto
Query
Dec-07-2020
02:01:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Jayesh Yeole
(pfe.yeolej)Query 3: Opened DM:
Erroneous
Visit is
marked, but
date of visit is
entered. Please
either, untick
the erroneous
visit button if
visit occurred
and update the
SAMP TRK
form according
or else clarify.
Dec-04-2020
07:50:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Dec-04-2020
07:50:15
(UTC-05:00)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Dec/3/2020Transcription
Error
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139684
Page 251 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)
Dec-04-2020
07:50:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Visit,
31/Dec/2020 is
a future date
relative to
when it was
entered on
04/Dec/2020.
Please correct.
Dec-04-2020
07:50:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Dec/31/2020Transcription
Error
Dec-04-2020
07:49:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidat
eErroneous
Visit is
marked, but
date of visit is
entered. Please
check whether
other
assessments
are performed
at this visit.
Dec-04-2020
07:49:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Visit,
30/Dec/2020 is
a future date
relative to
when it was
entered on
04/Dec/2020.
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139685
Page 252 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Please correct.
Dec-04-2020
07:49:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Dec/30/2020Transcription
Error
Nov-07-2020
01:46:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Vijay
Venugopal
(pfe.venugv04)Query 1: Closed Response
satisfies query
Nov-06-2020
08:20:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 1: Answere
dChanged data
per query
Nov-06-2020
00:38:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Jayesh Yeole
(pfe.yeolej)Query 1: Opened DM: Visit is
marked as
Erroneous.
However, form
level comment
is not present
on SAMP
TRK form.
Please review
and add form
level comment
by selecting as
Not Applicable
on SAMP
TRK form of
this visit or
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139686
Page 253 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
else clarify.
Thank you.
Nov-05-2020
16:59:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eErroneous
Visit is
marked, but
date of visit is
entered. Please
check whether
other
assessments
are performed
at this visit.
Nov-05-2020
16:58:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/5/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Dec-07-2020
08:23:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry: Transcription
Error
Nov-05-2020
16:59:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ERRONEOUS VI
SITInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139687
Page 254 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020
08:20:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-05-2020
16:59:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription
Error
Nov-05-2020
16:58:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020
08:20:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Nov-05-2020 ACV0PFEINFP6000  auto calc Data Entry: Transcription
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139688
Page 255 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
16:59:26
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) Error
Nov-05-2020
16:58:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
08:20:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Not ApplicableInitial Entry
Nov-05-2020
16:59:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-05-2020
16:59:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry: Transcription
Error
Nov-05-2020
16:58:51
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139689
Page 256 of 428
***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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-05-2020
16:58:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collecti
on:
Nov/5/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Nov-06-2020
08:20:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Not ApplicableInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139690
Page 257 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-05-2020
11:55:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-05-2020
11:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidat
eDate of Visit
is completed
but Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Nov-05-2020
11:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eDate of Visit
is completed
but Date of
Collection in
both Nasal
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139691
Page 258 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Nov-05-2020
11:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Nov/5/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-05-2020
11:55:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139692
Page 259 of 428
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/5/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Nov/4/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
Date of Last Sympt
om Resolved:
Nov/4/2020Initial Entry
4.a
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139693
Page 260 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sympt
oms:NEW OR I
NCREASEInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139694
Page 261 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)D COUGH
Sympt
om Pre
sent:NO
4.b Symptoms:
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sym
ptom
s:NEW OR IN
CREASED S
HORTNESS
OF BREATHInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139695
Page 262 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131718 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sym
ptom
Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NEW OR INCREAS
ED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-05-2020
17:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae2f57\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139696
Page 263 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16
…[truncated]