125742 S1 M5 CRF c4591001 1013 10131699

Document text

Page 1 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139023
Page 2 of 412
***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: 10131699 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/13/2020
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139024
Page 3 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131699]
2.Birth Date: /1960
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0139025
Page 4 of 412
***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: 10131699 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/13/2020
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139026
Page 5 of 412
***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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139027
Page 6 of 412
***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: 10131699 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/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139028
Page 7 of 412
***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: 10131699 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:[SUBTOTAL ABDOMINAL HYSTERECTOMY]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HERNIATED DISC C4-C6]
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HERNIATED DISC FUSION C4-C6]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139029
Page 8 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTRIC BYPASS]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BINGE EATING DISORDER]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139030
Page 9 of 412
***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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139031
Page 10 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
2.Weight: [60.2]
3.Unit: kg
4.Height: [158.0]
5.Unit: cm
6.Body Mass Index: [24.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139032
Page 11 of 412
***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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139033
Page 12 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/13/2020
2.Randomization Number: [268763]
3.Randomization Group: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139034
Page 13 of 412
***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: 10131699 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/13/2020
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 [BRD74R]
5.bSample ID [BRD74S]
5.cSample ID [BRD74T]
5.dSample ID [BSJT9T]
5.eSample ID [BSJT9V]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139035
Page 14 of 412
***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: 10131699 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/13/2020
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 [BRG2Y2]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139036
Page 15 of 412
***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: 10131699 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/13/2020 10:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139037
Page 16 of 412
***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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139038
Page 17 of 412
***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: 10131699 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/9/2020
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139039
Page 18 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Nov/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139040
Page 19 of 412
***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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139041
Page 20 of 412
***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: 10131699 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/9/2020
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 [BR9TN4]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139042
Page 21 of 412
***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: 10131699 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/9/2020 10:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139043
Page 22 of 412
***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: 10131699 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/7/2020
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139044
Page 23 of 412
***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: 10131699 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/7/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRHWFV]
5.bSample ID [BRHWFW]
5.cSample ID [BRHWFX]
5.dSample ID [BS3801]
5.eSample ID [BS3802]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139045
Page 24 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139046
Page 25 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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: Dec/11/2020
2.Date of First Symptom Started: Dec/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/20/2020
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139047
Page 26 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [FATIGUE]
5.bSymptoms - Other Text: [HEADACHE]
5.cSymptoms - Other Text: [NASAL CONGESTION]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139048
Page 27 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Lo
cationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable
 Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139049
Page 28 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139050
Page 29 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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:[SAMPLE COLLECTED AT VISIT]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139051
Page 30 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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:
Dec/11/2020
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 [BRHVRN]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139052
Page 31 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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
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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139053
Page 32 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139054
Page 33 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139055
Page 34 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139056
Page 35 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139057
Page 36 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139058
Page 37 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category f
or Lab Tes
tVendor NameCollect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
 1.CLINICA
L CHEMI
STRY ORLANDO REGIONAL MEDIC
AL CENTER, 1414 KUHL AVE.
ORLANDO, FL 32806 Jan/15/
2021 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329  C Reactive Pr
otein_PX329 1.0 
30  Alanine Ami
notransferase
_PX30 30 
28  Aspartate Am
inotransferase
_PX28 24 
35  Alkaline Phos
phatase_PX3
5 91 
21  Bilirubin_PX
21 0.4 
47  Blood Urea N
itrogen_PX47
 19 
48  Creatinine_P
X48 0.7
1 Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139059
Page 38 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category f
or Lab Tes
tVendor NameCollect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
 2.CLINICA
L CHEMI
STRY ORLANDO REGIONAL MEDIC
AL CENTER, 1414 KUHL AVE.
ORLANDO, FL 32806 Dec/11
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329  C Reactive Pr
otein_PX329 1.0 
30  Alanine Ami
notransferase
_PX30 40 
28  Aspartate Am
inotransferase
_PX28 31 
35  Alkaline Phos
phatase_PX3
5 98 
21  Bilirubin_PX
21 0.4 
47  Blood Urea N
itrogen_PX47
 17 
48  Creatinine_P
X48 0.6
9 Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139060
Page 39 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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: Jan/15/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.0]
Not Done:
LNMT Low
[ ]
High
[9.9]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [30]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139061
Page 40 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [24]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [91]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139062
Page 41 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.71]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139063
Page 42 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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/11/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.0]
Not Done:
LNMT Low
[ ]
High
[9.9]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [40]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139064
Page 43 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [31]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [98]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139065
Page 44 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [17]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.69]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139066
Page 45 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
 1.HEMATO
LOGY ORLANDO REGIONAL MEDICAL
CENTER, 1414 KUHL AVE. ORLA
NDO, FL 32806 Jan/15/
2021 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
1  Hemoglo
bin_PX1 13.
1 
2  Hematocr
it_PX2 40.
0 
3  Erythrocy
tes_PX3 4.3
4 
5  Platelets_
PX5 296
 
7  Leukocyt
es_PX7 6.6 
608  Neutroph
ils_PX60
8 3.5 
609  Eosinoph
ils_PX60
9 0.1 
612  Monocyt
es_PX61
2 0.4 
610  Basophils
_PX610 0.0 
611  Lymphoc
ytes_PX6
11 2.6 Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139067
Page 46 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
 2.HEMATO
LOGY ORLANDO REGIONAL MEDICAL
CENTER, 1414 KUHL AVE. ORLA
NDO, FL 32806 Dec/11/
2020 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
1  Hemoglo
bin_PX1 12.
5 
2  Hematocr
it_PX2 40.
8 
3  Erythrocy
tes_PX3 4.2
8 
5  Platelets_
PX5 286
 
7  Leukocyt
es_PX7 6.1 
608  Neutroph
ils_PX60
8 3.5 
609  Eosinoph
ils_PX60
9 0.0 
612  Monocyt
es_PX61
2 0.3 
610  Basophils
_PX610 0.0 
611  Lymphoc
ytes_PX6
11 2.3 Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139068
Page 47 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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: Jan/15/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.1]
Not Done:
LNMT Low
[11.4]
High
[14.7]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40.0]
Not Done:
LNMT Low
[34.3]
High
[45.5]
Unit
%
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139069
Page 48 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.34]
Not Done:
LNMT Low
[3.75]
High
[5.00]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [296]
Not Done:
LNMT Low
[139]
High
[361]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.6]
Not Done:
LNMT Low
[4.4]
High
[10.5]
Unit
10^3/uL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139070
Page 49 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.4]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139071
Page 50 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.6]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139072
Page 51 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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/11/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.5]
Not Done:
LNMT Low
[11.4]
High
[14.7]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40.8]
Not Done:
LNMT Low
[34.3]
High
[45.5]
Unit
%
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139073
Page 52 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.28]
Not Done:
LNMT Low
[3.75]
High
[5.00]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [286]
Not Done:
LNMT Low
[139]
High
[361]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.1]
Not Done:
LNMT Low
[4.4]
High
[10.5]
Unit
10^3/uL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139074
Page 53 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139075
Page 54 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.3]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139076
Page 55 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 1.Dec/11/2020 Record Identifier: Systolic: Diastolic:
1  102  64 Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139077
Page 56 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: VITAL SIGNS - COVID
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: 10131699 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: Dec/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [102]
Diastolic: [64]
Respiratory Rate in
respirations/minute:[15]
Heart Rate in beats/minute: [70]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139078
Page 57 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 1.Dec/11/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139079
Page 58 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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: Dec/11/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139080
Page 59 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139081
Page 60 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139082
Page 61 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139083
Page 62 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139084
Page 63 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139085
Page 64 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139086
Page 65 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: 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: 10131699 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/12/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139087
Page 66 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.          Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139088
Page 67 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139089
Page 68 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139090
Page 69 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139091
Page 70 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139092
Page 71 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139093
Page 72 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139094
Page 73 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139095
Page 74 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139096
Page 75 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139097
Page 76 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139098
Page 77 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139099
Page 78 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139100
Page 79 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139101
Page 80 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139102
Page 81 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139103
Page 82 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139104
Page 83 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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.Start Date: //
6.Ongoing?
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Page 84 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139106
Page 85 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
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FDA-CBER-2021-5683-0139107
Page 86 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/15/2021Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139108
Page 87 of 412
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/15/2021Form: 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: 10131699 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:
Jan/15/2021
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 [BRK9KM]
5.bSample ID [BRK9KN]
5.cSample ID [BRK9KP]
5.dSample ID [BSLR7M]
5.eSample ID [BSLR7N]
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FDA-CBER-2021-5683-0139109
Page 88 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
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FDA-CBER-2021-5683-0139110
Page 89 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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FDA-CBER-2021-5683-0139111
Page 90 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  KKIDNEY STO
NES Feb/19/2021 UNK:
UNK YES  Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139112
Page 91 of 412
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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)[KKIDNEY STONES]
4.Start Date Time: Feb/19/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
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FDA-CBER-2021-5683-0139113
Page 92 of 412
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021259828]
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FDA-CBER-2021-5683-0139114
Page 93 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139115
Page 94 of 412
***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: 10131699 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[ ]
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FDA-CBER-2021-5683-0139116
Page 95 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139117
Page 96 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
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FDA-CBER-2021-5683-0139118
Page 97 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139119
Page 98 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
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FDA-CBER-2021-5683-0139120
Page 99 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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FDA-CBER-2021-5683-0139121
Page 100 of 412
***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: 10131699 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?
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FDA-CBER-2021-5683-0139122
Page 101 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
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FDA-CBER-2021-5683-0139123
Page 102 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
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FDA-CBER-2021-5683-0139124
Page 103 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139125
Page 104 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
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FDA-CBER-2021-5683-0139126
Page 105 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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FDA-CBER-2021-5683-0139127
Page 106 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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-2021-5683-0139128
Page 107 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 10131699 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-2021-5683-0139129
Page 108 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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-2021-5683-0139130
Page 109 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139131
Page 110 of 412
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139132
Page 111 of 412
***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: 10131699 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/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139133
Page 112 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139134
Page 113 of 412
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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 local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139135
Page 114 of 412
***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: 10131699 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: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139136
Page 115 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139137
Page 116 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139138
Page 117 of 412
***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: 10131699 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: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139139
Page 118 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139140
Page 119 of 412
***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: 10131699 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
Jan/15/2021
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139141
Page 120 of 412
***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: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139142
Page 121 of 412
***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: 10131699 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
:Jan/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139143
Page 122 of 412
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139144
Page 123 of 412
***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: 10131699 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SAMPLE COLLECTED AT CO-OCCURRING CONV VISIT]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
5.eSample ID [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139145
Page 124 of 412
***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: 10131699 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:
Jan/15/2021
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 [BRBRKD]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139146
Page 125 of 412
***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: 10131699 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: Jan/15/2021 11:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139147
Page 126 of 412
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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/4/2021
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139148
Page 127 of 412
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139149
Page 128 of 412
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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/4/2021
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 [BRBRWZ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139150
Page 129 of 412
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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/4/2021 14:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139151
Page 130 of 412
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139152
Page 131 of 412
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/8/2021
3.Comments: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139153
Page 132 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139154
Page 133 of 412
***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: 10131699 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: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139155
Page 134 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139156
Page 135 of 412
***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: 10131699 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: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139157
Page 136 of 412
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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
:Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139158
Page 137 of 412
***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: 10131699 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/7/2020
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139159
Page 138 of 412
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 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
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139160
Page 139 of 412
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139161
Page 140 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-13-2020 15:58:56 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139162
Page 141 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139163
Page 142 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Oct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139164
Page 143 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Oct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139165
Page 144 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Oct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139166
Page 145 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Oct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139167
Page 146 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Oct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139168
Page 147 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139169
Page 148 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139170
Page 149 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-13-2020 16:09:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139171
Page 150 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139172
Page 151 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139173
Page 152 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139174
Page 153 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139175
Page 154 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139176
Page 155 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Nov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139177
Page 156 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139178
Page 157 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139179
Page 158 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-09-2020 14:40:09 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139180
Page 159 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139181
Page 160 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139182
Page 161 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139183
Page 162 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139184
Page 163 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139185
Page 164 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139186
Page 165 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139187
Page 166 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139188
Page 167 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139189
Page 168 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Dec-11-2020 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139190
Page 169 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-11-2020 11:39:54 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139191
Page 170 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-11-2020 11:39:54 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139192
Page 171 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-11-2020 11:39:54 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139193
Page 172 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-11-2020 11:39:54 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139194
Page 173 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-11-2020 11:39:54 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139195
Page 174 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Dec-11-2020 11:39:54 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139196
Page 175 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Dec-11-2020 11:39:54 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139197
Page 176 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-11-2020 11:41:08 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139198
Page 177 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-11-2020 11:41:08 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139199
Page 178 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-11-2020 11:41:08 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139200
Page 179 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-11-2020 11:41:08 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139201
Page 180 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-11-2020 11:41:08 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139202
Page 181 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-11-2020 11:43:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139203
Page 182 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-11-2020 11:43:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139204
Page 183 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-11-2020 11:43:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139205
Page 184 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-11-2020 11:43:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139206
Page 185 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-11-2020 11:43:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139207
Page 186 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-11-2020 11:43:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139208
Page 187 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-11-2020 11:43:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139209
Page 188 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-11-2020 11:43:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139210
Page 189 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-11-2020 11:43:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139211
Page 190 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Dec-11-2020 11:43:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139212
Page 191 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Dec-11-2020 11:43:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139213
Page 192 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-11-2020 11:44:03 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139214
Page 193 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-11-2020 11:44:03 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139215
Page 194 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-11-2020 11:44:03 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139216
Page 195 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-11-2020 11:44:03 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139217
Page 196 of 412
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/11/2020Form: 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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-11-2020 11:44:03 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139218
Page 197 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormJan-18-2021 19:12:27 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139219
Page 198 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormJan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139220
Page 199 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Jan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139221
Page 200 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Jan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139222
Page 201 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Jan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139223
Page 202 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Jan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139224
Page 203 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Jan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139225
Page 204 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aJan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139226
Page 205 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aJan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139227
Page 206 of 412
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aJan-18-2021 19:13:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139228
Page 207 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139229
Page 208 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139230
Page 209 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139231
Page 210 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139232
Page 211 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139233
Page 212 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Feb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139234
Page 213 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139235
Page 214 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139236
Page 215 of 412
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-08-2021 17:06:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139237
Page 216 of 412
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Scott Salmon  N/A Mar-12-2021 11:38:11 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever  Approved Mar-11-2021 09:24:26 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Scott Salmon  N/A Mar-10-2021 11:53:04 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia Brown  Approved Feb-25-2021 14:44:33 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaBrown, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139238
Page 217 of 412
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Scott Salmon  N/A Feb-08-2021 17:05:06 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever  Approved Feb-01-2021 09:46:52 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Scott Salmon  N/A Jan-25-2021 16:40:25 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever  Approved Jan-22-2021 06:58:08 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Scott Salmon  N/A Jan-21-2021 11:32:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139239
Page 218 of 412
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Michael Dever  Approved Jan-20-2021 14:30:41 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139240
Page 219 of 412
***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: 10131699 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-13-2020 15:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-13-2020 15:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139241
Page 220 of 412
***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: 10131699 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-13-2020 15:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/13/2020Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139242
Page 221 of 412
***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: 10131699 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-13-2020 15:56:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10131699Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-13-2020 15:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1960Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-13-2020 15:58:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-13-2020 15:58:08
(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-13-2020 15:58:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
WHITEInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0139243
Page 222 of 412
***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: 10131699 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-13-2020 15:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/13/2020Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139244
Page 223 of 412
***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: 10131699 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-13-2020 15:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020 15:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020 15:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139245
Page 224 of 412
***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: 10131699 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-15-2020 08:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Line/MH
Number:1
Medical
History
Term:SUBTOTAL ABD
OMINAL HYSTER
ECTOMY
Start Dat
e:UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994Transcription Error
Oct-13-2020 16:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Line/MH
Number:1
Medical
History
Term:SUBTOTAL ABD
OMINAL HYSTER
ECTOMY
Start Dat
e:UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994Transcription Error
Oct-13-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:SUBTOAL ABDO
MINAL HYSTERE
CTOMY
Start Dat
e:UNK/UNK/1994Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139246
Page 225 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Date:
UNK/UNK/199
4
1.a Line/MH Number:
Date Location User Value Reason
Oct-13-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 09:57:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
Oct-15-2020 08:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-15-2020 08:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
SUBTOTAL ABDOMINAL H
YSTERECTOMYTranscription Error
Oct-15-2020 01:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Swaranjali
Subhash Pawar
(pfe.pawars01)Query 1: Opened DM: A trailing
space is identified.
To avoid processing
errors, please
remove the
identified character
by deleting the
entry and
re-entering the data
(without using copy
and paste).
Oct-13-2020 16:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
SUBTOTAL ABDOMINAL H
YSTERECTOMYTranscription Error
Oct-13-2020 16:00:50
(UTC-05:00) EasternACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
SUBTOAL ABDOMINAL HYInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139247
Page 226 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) STERECTOMY
1.a Start Date:
Date Location User Value Reason
Oct-13-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
UNK/UNK/1994Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-13-2020 16:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date:
UNK/UNK/1994Initial Entry
1.b
Date Location User Value Reason
Oct-13-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:HERNIATED DI
SC C4-C6
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
Jun/UNK/2020Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139248
Page 227 of 412
***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: 10131699 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-13-2020 16:04:51
(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-13-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
HERNIATED DISC C4-C6Initial Entry
1.b Start Date:
Date Location User Value Reason
Oct-13-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Jan/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-13-2020 16:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date:
Jun/UNK/2020Initial Entry
1.c
Date Location User Value Reason
Oct-13-2020 16:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:HERNIATED DISC
FUSION C4-C6
Start Date: Jun/UNK/2020Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139249
Page 228 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Date:
Jun/UNK/2020
1.c Line/MH Number:
Date Location User Value Reason
Oct-13-2020 16:06:25
(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-13-2020 16:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
HERNIATED DISC FUSION C4
-C6Initial Entry
1.c Start Date:
Date Location User Value Reason
Oct-13-2020 16:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Jun/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-13-2020 16:06:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date:
Jun/UNK/2020Initial Entry
1.d
Date Location User Value Reason
Oct-13-2020 16:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139250
Page 229 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical History
Term:GASTRIC BYP
ASS
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/
2018
1.d Line/MH Number:
Date Location User Value Reason
Oct-13-2020 16:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 16:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
GASTRIC BYPASSInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-13-2020 16:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-13-2020 16:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.e
Date Location User Value Reason
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139251
Page 230 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-13-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:BINGE EATING
DISORDER
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/201
8Initial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-13-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
BINGE EATING DISORDERInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-13-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
UNK/UNK/1989Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-13-2020 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139252
Page 231 of 412
***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: 10131699 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-13-2020 16:08:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139253
Page 232 of 412
***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: 10131699 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-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
60.2Initial Entry
3. Unit:
Date Location User Value Reason
Oct-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
158.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-13-2020 16:08:58
(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-13-2020 16:08:58
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.1Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139254
Page 233 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Record Identifier:
:1
Temperature: 36.8
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-13-2020 16:08:58
(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-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-13-2020 16:08:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139255
Page 234 of 412
***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: 10131699 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-13-2020 16:09:21
(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-13-2020 16:09:21
(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-13-2020 16:09:21
(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-13-2020 16:09:21
(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
Oct-13-2020 16:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139256
Page 235 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-13-2020 16:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-13-2020 16:09:21
(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
Oct-13-2020 16:09:21
(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-13-2020 16:09:21
(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-13-2020 16:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Not ApplicableInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139257
Page 236 of 412
***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: 10131699 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-13-2020 16:10:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-13-2020 16:10:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
268763Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139258
Page 237 of 412
***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: 10131699 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-13-2020 16:10:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 16:10:32
(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 07:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 16:10:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-13-2020 16:10:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020 07:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRD74RInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139259
Page 238 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 07:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BRD74RInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020 07:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRD74SInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020 07:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BRD74SInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020 07:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRD74TInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020 07:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BRD74TInitial Entry
5.d
Date Location User Value Reason
Oct-14-2020 07:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BSJT9TInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139260
Page 239 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Oct-14-2020 07:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BSJT9TInitial Entry
5.e
Date Location User Value Reason
Oct-14-2020 07:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BSJT9VInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-14-2020 07:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BSJT9VInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139261
Page 240 of 412
***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: 10131699 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-13-2020 16:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 16:10:51
(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 07:50:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 16:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-13-2020 16:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020 07:50:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRG2Y2Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139262
Page 241 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 07:50:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BRG2Y2Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139263
Page 242 of 412
***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: 10131699 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-13-2020 16:11:25
(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-13-2020 16:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020 16:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-13-2020 16:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
Oct/13/2020 10:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020 16:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-13-2020 16:11:25
(UTC-05:00) EasternACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
RIGHTInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139264
Page 243 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-13-2020 16:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-13-2020 16:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-13-2020 16:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139265
Page 244 of 412
***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: 10131699 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-13-2020 16:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Scott Salmon
(pfe.ssalmon)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139266
Page 245 of 412
***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: 10131699 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-11-2020 01:23:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Annam
Sireesha
(pfe.sireea)Query 1: Closed Closed as per site
response, updated
PD tracker for
clinical review
Nov-10-2020 07:47:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 1: Answered DATES ARE
CORRECT AS
RECORDED.
Nov-10-2020 03:14:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Avinash Gawas
(pfe.gawasa)Query 1: Opened PDQ: DOV at this
visit is out of
window (4 day)
from DOV (13/Oct
/2020) at
V1D1VX1L. Please
either update DOV
or confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Nov-09-2020 14:39:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Nov/9/2020Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139267
Page 246 of 412
***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: 10131699 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-09-2020 14:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Nov/9/2020Initial Entry
2.a
Date Location User Value Reason
Nov-09-2020 14:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Record Identifier
::1
Temperature: 36.5
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-09-2020 14:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-09-2020 14:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-09-2020 14:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
CInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139268
Page 247 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.a Temperature Location:
Date Location User Value Reason
Nov-09-2020 14:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139269
Page 248 of 412
***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: 10131699 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-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139270
Page 249 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-09-2020 14:40:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Not ApplicableInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139271
Page 250 of 412
***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: 10131699 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-09-2020 14:40:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-09-2020 14:40:22
(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-09-2020 17:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-09-2020 14:40:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-09-2020 14:40:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:
Nov/9/2020Initial Entry
5.a
Date Location User Value Reason
Nov-09-2020 17:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BR9TN4Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139272
Page 251 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Nov-09-2020 17:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BR9TN4Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139273
Page 252 of 412
***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: 10131699 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-09-2020 14:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-09-2020 14:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-09-2020 14:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-09-2020 14:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Nov/9/2020 10:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-09-2020 14:40:35
(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-09-2020 14:40:35
(UTC-05:00) EasternACV0PFEINFP6000  Matthew
StephensData Entry:
RIGHTInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139274
Page 253 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe mstephens)
7. Route:
Date Location User Value Reason
Nov-09-2020 14:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-09-2020 14:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-09-2020 14:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
YESInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139275
Page 254 of 412
***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: 10131699 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 13:25:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Dec/7/2020Initial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139276
Page 255 of 412
***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: 10131699 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
Dec-07-2020 13:25:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-07-2020 13:25:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-07-2020 17:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-07-2020 13:25:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-07-2020 13:25:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-07-2020 17:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRHWFVInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139277
Page 256 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Dec-07-2020 17:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BRHWFVInitial Entry
5.b
Date Location User Value Reason
Dec-07-2020 17:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BRHWFWTranscription Error
Dec-07-2020 17:03:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BRHWFVInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-07-2020 17:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRHWFWTranscription Error
Dec-07-2020 17:03:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRHWFVInitial Entry
5.c
Date Location User Value Reason
Dec-07-2020 17:04:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRHWFXInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-07-2020 17:04:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
BRHWFXInitial Entry
090177e196ae2f5d\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0139278
Page 257 of 412
***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: 10131699 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d
Date Location User Value Reason
Dec-07-2020 17:04:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BS3801Initial Entry
5.d Sample ID
Date Location User Value Reason
Dec-07-2020 17:04:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe mstephens)Data 
…[truncated]