Document text
Page 1 of 463
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138087
Page 2 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/16/2020
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138088
Page 3 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131554]
2.Birth Date: 1961
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:
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
FDA-CBER-2021-5683-0138089
Page 4 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138090
Page 5 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138091
Page 6 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138092
Page 7 of 463
***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: 10131554 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:[cholecystitis]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[herniated disc C-5]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138093
Page 8 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[surgical fusion of C5]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[cholecystectomy]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[total abdominal hysterectomy]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138094
Page 9 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[bilateral oophorectomy]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[bilateral salpingectomy]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[endometriosis]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2009
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138095
Page 10 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: UNK/UNK/2017
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypercholesterolemia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[rheumatoid arthritis in remission]
Start Date: UNK/UNK/2010
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[asthma]
Start Date: UNK/UNK/1968
Ongoing: YES
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138096
Page 11 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[seasonal allergies]
Start Date: UNK/UNK/1972
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[irritable bowel syndrome]
Start Date: UNK/UNK/2014
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[obesity]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138097
Page 12 of 463
***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: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138098
Page 13 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
2.Weight: [94.6]
3.Unit: kg
4.Height: [166.5]
5.Unit: cm
6.Body Mass Index: [34.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138099
Page 14 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138100
Page 15 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/16/2020
2.Randomization Number: [260125]
3.Randomization Group: [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138101
Page 16 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPC361]
5.bSample ID [BPC362]
5.cSample ID [BPC363]
5.dSample ID [BMN4PK]
5.eSample ID [BMN4PL]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138102
Page 17 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPC2ZY]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138103
Page 18 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 11:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138104
Page 19 of 463
***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: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138105
Page 20 of 463
***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: 10131554 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/5/2020 Comments
2.Erroneous Visit
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138106
Page 21 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138107
Page 22 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138108
Page 23 of 463
***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: 10131554 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/5/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRG2S3]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138109
Page 24 of 463
***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: 10131554 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/5/2020 15:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138110
Page 25 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138111
Page 26 of 463
***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: 10131554 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:
Nov/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSHPXL]
5.bSample ID [BSHPXM]
5.cSample ID [BR646F]
5.dSample ID [BR646G]
5.eSample ID [BR646H]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138112
Page 27 of 463
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138113
Page 28 of 463
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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 [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138114
Page 29 of 463
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138115
Page 30 of 463
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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 [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138116
Page 31 of 463
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138117
Page 32 of 463
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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 [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138118
Page 33 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10131554 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/14/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138119
Page 34 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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/14/2020
2.Date of First Symptom
Started:Nov/13/2020
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? YES
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? NO
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138120
Page 35 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [HEADACHE]
5.bSymptoms - Other Text: [NASAL CONGESTION]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138121
Page 36 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice T
ypeForm Instan
ce
1.Not Applic
able Not Appli
cable Not Applicable Not Applicable Not Appli
cable Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138122
Page 37 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138123
Page 38 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[SWAB COLLECTED IN OFFICE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138124
Page 39 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: 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: 10131554 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/14/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRHVRV]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138125
Page 40 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138126
Page 41 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138127
Page 42 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
1.Not Applicab
le Not Applicable Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138128
Page 43 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138129
Page 44 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: 2
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138130
Page 45 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138131
Page 46 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138132
Page 47 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
y for La
b TestVendor NameColle
ction
Date
:Speci
men
TypeLab ResultForm Inst
ance
1.CLINIC
AL CH
EMIST
RY ORLANDO REGIONA
L MEDICAL CENTER
1414 KUHL AVE ORL
ANDO FL 32806 Dec/
14/20
20 BLO
OD Sponso
r-Defin
ed Iden
tifierTest:Re
sul
t:
329 C Reactiv
e Protein_
PX329 9.4
30 Alanine A
minotrans
ferase_PX
30 22
28 Aspartate
Aminotra
nsferase_
PX28 17
35 Alkaline
Phosphata
se_PX35 94
21 Bilirubin_
PX21 0.2
47 Blood Ure
a Nitroge
n_PX47 17
48 Creatinine
_PX48 0.5
3 Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138133
Page 48 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
y for La
b TestVendor NameColle
ction
Date
:Spec
imen
TypeLab ResultForm Inst
ance
2.CLINIC
AL CH
EMIST
RY ORLANDO REGIONA
L MEDICAL CENTER,
1414 KUHL AVE. ORL
ANDO, FL 32806 Jan/1
2/202
1 BLO
OD Sponso
r-Defin
ed Iden
tifierTest:Re
sul
t:
329 C Reactiv
e Protein_
PX329 20.
7
30 Alanine A
minotrans
ferase_PX
30 31
28 Aspartate
Aminotra
nsferase_
PX28 21
35 Alkaline
Phosphata
se_PX35 85
21 Bilirubin_
PX21 0.2
47 Blood Ur
ea Nitrog
en_PX47 24
48 Creatinine
_PX48 0.6
8 Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138134
Page 49 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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/14/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [9.4]
Not Done:
LNMT Low
[ ]
High
[9.9]
Unit
mg/L
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138135
Page 50 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [22]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [17]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138136
Page 51 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [94]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.2]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138137
Page 52 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: [0.53]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138138
Page 53 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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/12/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [20.7]
Not Done:
LNMT Low
[ ]
High
[9.9]
Unit
mg/L
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138139
Page 54 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [31]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [21]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138140
Page 55 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [85]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.2]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138141
Page 56 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [24]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.68]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138142
Page 57 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ry for
Lab Te
stVendor Name (DERIVE
D)Colle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
1.HEMA
TOLO
GY ORLANDO REGIONAL
MEDICAL CENTER 141
4 KUHL AVE ORLAND
O FL 32806 Dec/1
4/202
0 BLO
OD Sponsor
-Define
d Identi
fierTest:Re
sul
t:
1 Hemog
lobin_
PX1 12.
6
2 Hemat
ocrit_P
X2 43.
2
3 Erythro
cytes_
PX3 4.7
8
5 Platelet
s_PX5 38
5
7 Leukoc
ytes_P
X7 11.
6
608 Neutro
phils_P
X608 6.2
609 Eosino
phils_P
X609 0.1
Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138143
Page 58 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ry for
Lab Te
stVendor Name (DERIVE
D)Colle
ction
Date:Speci
men
TypeLab ResultForm Insta
nce
Sponsor
-Define
d Identi
fierTest:Re
sul
t:
612 Monoc
ytes_P
X612 0.5
610 Basoph
ils_PX
610 0.1
611 Lymph
ocytes_
PX611 4.7
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138144
Page 59 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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/14/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.6]
Not Done:
LNMT Low
[11.4]
High
[14.7]
Unit
g/dL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138145
Page 60 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [43.2]
Not Done:
LNMT Low
[34.3]
High
[45.5]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.78]
Not Done:
LNMT Low
[3.75]
High
[5.00]
Unit
10^6/cu mm
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138146
Page 61 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [385]
Not Done:
LNMT Low
[139]
High
[361]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [11.6]
Not Done:
LNMT Low
[4.4]
High
[10.5]
Unit
10^3/uL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138147
Page 62 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [6.2]
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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138148
Page 63 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.5]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138149
Page 64 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [4.7]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138150
Page 65 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
1.Dec/14/2020 Record Identifier: Systolic: Diastolic:
1 122 80 Repeating Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138151
Page 66 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
2.Jan/12/2021 Record Identifier: Systolic: Diastolic:
1 183 130 Repeating Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138152
Page 67 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [122]
Diastolic: [80]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in
beats/minute:[79]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138153
Page 68 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: Jan/12/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [183]
Diastolic: [130]
Respiratory Rate in
respirations/minute:[15]
Heart Rate in
beats/minute:[98]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138154
Page 69 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
1.Dec/14/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138155
Page 70 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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/14/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
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Page 71 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138157
Page 72 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138158
Page 73 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
1.Not Applicabl
e Not Applicab
le Not Applicable Not Applic
able Not App
licable Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138159
Page 74 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
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Page 75 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicable Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138161
Page 76 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138162
Page 77 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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/12/2021
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138163
Page 78 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1. Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138164
Page 79 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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: [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138165
Page 80 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138166
Page 81 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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?
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
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Page 82 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138168
Page 83 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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:
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138169
Page 84 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138170
Page 85 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138172
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
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FDA-CBER-2021-5683-0138173
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138174
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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:[ ]
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138176
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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 % [ ]
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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138178
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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):[ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138180
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138182
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/12/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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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***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
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FDA-CBER-2021-5683-0138184
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/12/2021Form: 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: 10131554 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/12/2021
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 [BRK9H7]
5.bSample ID [BRK9H8]
5.cSample ID [BRK9H9]
5.dSample ID [BS0YGC]
5.eSample ID [BS0YGD]
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FDA-CBER-2021-5683-0138185
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***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: 10131554 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:
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138186
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***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: 10131554 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 [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138187
Page 102 of 463
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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-2021-5683-0138188
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***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 INJECTION SI
TE PAIN Sep/17/2020
23:20 NO
End Date Time:
Sep/20/2020 08:0
0
Repeating
Pages
2.ADVERSE
EVENT 2 INJECTION PA
IN Oct/5/2020 2
2:00 NO
End Date Time:
Oct/6/2020 20:00
Repeating
Pages
3.ADVERSE
EVENT 3 BODY PAIN Oct/5/2020 2
2:00 NO
End Date Time:
Oct/6/2020 22:00
Repeating
Pages
4.ADVERSE
EVENT 4 LOW GRADE
FEVER Oct/6/2020 0
9:00 NO
End Date Time:
Oct/7/2020 22:00
Repeating
Pages
5.ADVERSE
EVENT 5 CHILLS Oct/6/2020 0
9:00 NO
End Date Time:
Oct/7/2020 22:00
Repeating
Pages
6.ADVERSE
EVENT 6 acute exacerbati
on of asthma Dec/16/2020
UNK:UNK NO
End Date Time:Repeating
Pages
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FDA-CBER-2021-5683-0138190
Page 105 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
Dec/20/2020 UN
K:UNK
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138191
Page 106 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[INJECTION SITE PAIN]
4.Start Date Time: Sep/17/2020 23:20
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/20/2020 08:00
6.Toxicity Grade: 1
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138192
Page 107 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138193
Page 108 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138194
Page 109 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[INJECTION PAIN]
4.Start Date Time: Oct/5/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/6/2020 20:00
6.Toxicity Grade: 2
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138195
Page 110 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138196
Page 111 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138197
Page 112 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[BODY PAIN]
4.Start Date Time: Oct/5/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/6/2020 22:00
6.Toxicity Grade: 1
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138198
Page 113 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138199
Page 114 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138200
Page 115 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[LOW GRADE FEVER]
4.Start Date Time: Oct/6/2020 09:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 22:00
6.Toxicity Grade: 1
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[CHILLS]
4.Start Date Time: Oct/6/2020 09:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 22:00
6.Toxicity Grade: 1
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FDA-CBER-2021-5683-0138204
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
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FDA-CBER-2021-5683-0138205
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
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FDA-CBER-2021-5683-0138206
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[acute exacerbation of asthma]
4.Start Date Time: Dec/16/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/20/2020 UNK:UNK
6.Toxicity Grade: 3
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FDA-CBER-2021-5683-0138207
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
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:
[Asthma]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
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FDA-CBER-2021-5683-0138208
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021026250]
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FDA-CBER-2021-5683-0138209
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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
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***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: 10131554 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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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
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***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
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***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: 10131554 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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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
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***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: 10131554 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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***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: 10131554 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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***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: 10131554 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-2021-5683-0138219
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***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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 :Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0138220
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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-2021-5683-0138221
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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-2021-5683-0138223
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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-2021-5683-0138224
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: [ ]
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FDA-CBER-2021-5683-0138225
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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: [ ]
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FDA-CBER-2021-5683-0138226
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***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
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***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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 [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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 [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138230
Page 145 of 463
***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: 10131554 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: [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138231
Page 146 of 463
***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: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138232
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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138233
Page 148 of 463
***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: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138234
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***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138235
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***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: 10131554 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: [ ]
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138236
Page 151 of 463
***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: 10131554 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 Nov/2/2020
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138237
Page 152 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 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
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138238
Page 153 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Jan-20-2021 13:09:17 (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.
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138239
Page 154 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-16-2020 13:44:31 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138240
Page 155 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138241
Page 156 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Sep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138242
Page 157 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Sep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138243
Page 158 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Sep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138244
Page 159 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Sep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138245
Page 160 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Sep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138246
Page 161 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138247
Page 162 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138248
Page 163 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-16-2020 13:57:36 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138249
Page 164 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Sep-17-2020 15:51:28 (UTC-05:00)
Eastern Time (US & Canada)Monica
Cooper
(pfe.mcooper)added in error; unable to delete date
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138250
Page 165 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138251
Page 166 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Oct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138252
Page 167 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Oct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138253
Page 168 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Oct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138254
Page 169 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Oct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138255
Page 170 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Oct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138256
Page 171 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138257
Page 172 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138258
Page 173 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-05-2020 16:19:36 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138259
Page 174 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-14-2020 13:55:53
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138260
Page 175 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138261
Page 176 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138262
Page 177 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138263
Page 178 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138264
Page 179 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138265
Page 180 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
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***Confidential***
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Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138267
Page 182 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138268
Page 183 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Dec-14-2020 13:55:53 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138269
Page 184 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-14-2020 13:56:42
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138270
Page 185 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-14-2020 13:56:42 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138271
Page 186 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-14-2020 13:56:42 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138272
Page 187 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-14-2020 13:56:42 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138273
Page 188 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-14-2020 13:56:42 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138274
Page 189 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Dec-14-2020 13:56:42 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138275
Page 190 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Dec-14-2020 13:56:42 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138276
Page 191 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-14-2020 13:57:08
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138277
Page 192 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-14-2020 13:57:08 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138278
Page 193 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-14-2020 13:57:08 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138279
Page 194 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-14-2020 13:57:08 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138280
Page 195 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-14-2020 13:57:08 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138281
Page 196 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-14-2020 13:57:52
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138282
Page 197 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-14-2020 13:57:52 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138283
Page 198 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-14-2020 13:57:52 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138284
Page 199 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-14-2020 13:57:52 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138285
Page 200 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-14-2020 13:58:06
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138286
Page 201 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-14-2020 13:58:06 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138287
Page 202 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-14-2020 13:58:06 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138288
Page 203 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-14-2020 13:58:06 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138289
Page 204 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-14-2020 13:58:06 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138290
Page 205 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Dec-14-2020 13:58:06 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138291
Page 206 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Dec-14-2020 13:58:06 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138292
Page 207 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-14-2020 13:58:20
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138293
Page 208 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-14-2020 13:58:20 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138294
Page 209 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-14-2020 13:58:20 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138295
Page 210 of 463
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-14-2020 13:58:20 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138296
Page 211 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-14-2020 13:58:20 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138297
Page 212 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Jan-20-2021 13:09:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Matthew
Stephens N/A Dec-14-2020 13:54:22 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Nov-06-2020 08:39:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138298
Page 213 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138299
Page 214 of 463
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-16-2020
13:43:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-16-2020
13:43:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138300
Page 215 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020
13:44:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/16/2020Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138301
Page 216 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020
13:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10131554Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020
13:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1961Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020
13:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
(b) (6)
FDA-CBER-2021-5683-0138302
Page 217 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020
13:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-16-2020
13:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
WHITEInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138303
Page 218 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020
13:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/16/2020Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138304
Page 219 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-16-2020
13:44:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020
13:44:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020
13:44:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138305
Page 220 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020
12:30:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:cholecysti
tis
Start Dat
e:UNK/UN
K/2009
Ongoing: NO
End Dat
e:
UNK/
UNK/2
009Initial Entry
Sep-17-2020
12:30:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:
Medical
History T
erm:
Start Dat
e:UNK/UN
K/2009Transcription
Error
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138306
Page 221 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Dat
e:
UNK/
UNK/2
009
Sep-16-2020
13:45:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:cholecysti
tis
Start Dat
e:UNK/UN
K/2009
Ongoing: NO
End Dat
e:
UNK/
UNK/2
009Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020
12:30:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138307
Page 222 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-17-2020
12:30:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Sep-16-2020
13:45:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
04:10:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response
satisfies query
Sep-17-2020
12:30:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
cholecystitisInitial Entry
Sep-17-2020
12:30:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dTranscription
Error
Sep-17-2020
12:30:45ACV0PFEINFP6000 Monica
CooperData Entry: Transcription
Error
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138308
Page 223 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper)
Sep-17-2020
11:56:19
(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).
Sep-16-2020
13:45:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
cholecystitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020
13:45:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2009Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138309
Page 224 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020
13:45:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.b
Date Location User Value Reason
Sep-16-2020
13:45:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:herniated d
isc C-5
Start Date
:UNK/UN
K/2003
Ongoing: NO
End Date
:
UNK/U
NK/200
3Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138310
Page 225 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:45:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:45:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
herniated disc C-5Initial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020
13:45:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2003Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020
13:45:22ACV0PFEINFP6000 Monica
CooperData Entry:
NOInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138311
Page 226 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper) End Date:
UNK/UNK/2003
1.c
Date Location User Value Reason
Sep-16-2020
13:45:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:surgical fu
sion of C5
Start Date
:UNK/UN
K/2003
Ongoing: NO
End Date
:
UNK/U
NK/200
3Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138312
Page 227 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:45:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:45:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
surgical fusion of C5Initial Entry
1.c Start Date:
Date Location User Value Reason
Sep-16-2020
13:45:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2003Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020
13:45:39ACV0PFEINFP6000 Monica
CooperData Entry:
NOInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138313
Page 228 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper) End Date:
UNK/UNK/2003
1.d
Date Location User Value Reason
Sep-16-2020
13:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:cholecyste
ctomy
Start Date
:UNK/UN
K/2009
Ongoing: NO
End Date
:
UNK/U
NK/200
9Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138314
Page 229 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
cholecystectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-16-2020
13:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2009Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020
13:45:56ACV0PFEINFP6000 Monica
CooperData Entry:
NOInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138315
Page 230 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper) End Date:
UNK/UNK/2009
1.e
Date Location User Value Reason
Sep-16-2020
13:46:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:5
Medical
History
Term:total abdomi
nal hysterect
omy
Start Da
te:UNK/UNK/
2009
Ongoing
:NO
End Date:
UNK/UN
K/2009Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138316
Page 231 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:46:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:46:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
total abdominal hyst
erectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-16-2020
13:46:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2009Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-16-2020
13:46:15ACV0PFEINFP6000 Monica
CooperData Entry:
NOInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138317
Page 232 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper) End Date:
UNK/UNK/2009
1.f
Date Location User Value Reason
Sep-16-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History T
erm:bilateral oo
phorectom
y
Start Dat
e:UNK/UNK
/2009
Ongoing: NO
End Date:
UNK/U
NK/200
9Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138318
Page 233 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.f Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
bilateral oophorecto
myInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-16-2020
13:46:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2009Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-16-2020
13:46:34ACV0PFEINFP6000 Monica
CooperData Entry:
NOInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138319
Page 234 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper) End Date:
UNK/UNK/2009
1.g
Date Location User Value Reason
Sep-16-2020
13:47:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:bilateral sal
pingectomy
Start Dat
e:UNK/UNK
/2009
Ongoing: NO
End Date:
UNK/U
NK/200
9Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138320
Page 235 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.g Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:47:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:47:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
bilateral salpingecto
myInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-16-2020
13:47:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2009Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-16-2020
13:47:34ACV0PFEINFP6000 Monica
CooperData Entry:
NOInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138321
Page 236 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper) End Date:
UNK/UNK/2009
1.h
Date Location User Value Reason
Sep-16-2020
13:47:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:endometri
osis
Start Date
:UNK/UN
K/2008
Ongoing: NO
End Date
:
UNK/U
NK/200
9Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138322
Page 237 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.h Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:47:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:47:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
endometriosisInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-16-2020
13:47:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2008Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-16-2020
13:47:57ACV0PFEINFP6000 Monica
CooperData Entry:
NOInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138323
Page 238 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper) End Date:
UNK/UNK/2009
1.i
Date Location User Value Reason
Sep-16-2020
13:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical His
tory Term:hyperten
sion
Start Date: UNK/U
NK/201
7
Ongoing: YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138324
Page 239 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
hypertensionInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-16-2020
13:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2017Initial Entry
1.i Ongoing:
Date Location User Value Reason
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138325
Page 240 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020
13:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-16-2020
13:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical Hi
story Term
:hyperchol
esterolem
ia
Start Date: UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138326
Page 241 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.j Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
hypercholesterolemi
aInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-16-2020
13:48:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-16-2020
13:48:21ACV0PFEINFP6000 Monica
CooperData Entry:
YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138327
Page 242 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper)
1.k
Date Location User Value Reason
Sep-16-2020
13:48:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
History
Term:rheumatoid
arthritis in r
emission
Start Da
te:UNK/UNK/
2010
Ongoing
:YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138328
Page 243 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.k Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:48:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-29-2020
06:29:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Gary Steven
Friedman
(pfe.friedg01)Query 1:
ClosedResponse satisfies query
Sep-28-2020
08:29:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 1:
Answere
dPER CRC SUBJECT IS
NOT TAKING ANY
MEDICATION FOR
RHEUMATOID
ARTHRITIS
Sep-26-2020
14:32:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Gary Steven
Friedman
(pfe.friedg01)Query 1:
OpenedRHEUMATOID
ARTHRITIS (ONGOING):
please confirm that
participant IS or IS NOT
receiving ORAL
CORTICOSTEROIDS OR
METHOTREXATE or
ORAL OR PARENTERAL
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138329
Page 244 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
IMMUNOMODULATORS
currently to maintain
remission.
Sep-16-2020
13:48:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Monica Cooper
(pfe.mcooper)Data Ent
ry:
rheumato
id arthriti
s in remi
ssionInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-16-2020
13:48:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2010Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-16-2020
13:48:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138330
Page 245 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020
13:49:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical His
tory Term:asthma
Start Date: UNK/U
NK/196
8
Ongoing: YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138331
Page 246 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.l Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:49:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:49:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
asthmaInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-16-2020
13:49:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/1968Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-16-2020
13:49:03ACV0PFEINFP6000 Monica
CooperData Entry:
YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138332
Page 247 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper)
1.m
Date Location User Value Reason
Sep-16-2020
13:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical His
tory Term:seasonal
allergies
Start Date: UNK/U
NK/1972
Ongoing: YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138333
Page 248 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.m Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
seasonal allergiesInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-16-2020
13:49:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/1972Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-16-2020
13:49:15ACV0PFEINFP6000 Monica
CooperData Entry:
YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138334
Page 249 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper)
1.n
Date Location User Value Reason
Sep-16-2020
13:49:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical
History T
erm:irritable bo
wel syndro
me
Start Date
:UNK/UN
K/2014
Ongoing: YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138335
Page 250 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.n Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:49:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:49:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
irritable bowel syndr
omeInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-16-2020
13:49:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2014Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-16-2020
13:49:37ACV0PFEINFP6000 Monica
CooperData Entry:
YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138336
Page 251 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper)
1.o
Date Location User Value Reason
Sep-16-2020
13:49:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:15
Medical His
tory Term:obesity
Start Date: UNK/U
NK/201
6
Ongoing: YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138337
Page 252 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.o Line/MH Number:
Date Location User Value Reason
Sep-16-2020
13:49:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
13:49:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
obesityInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-16-2020
13:49:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
UNK/UNK/2016Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-16-2020
13:49:49ACV0PFEINFP6000 Monica
CooperData Entry:
YESInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138338
Page 253 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper)
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138339
Page 254 of 463
***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: 10131554 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
Sep-16-2020
13:50:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
The subject is NOT
known to be HIV PO
SITIVEInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138340
Page 255 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
94.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138341
Page 256 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
166.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.1Initial Entry
7.a
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.4Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138342
Page 257 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
CInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138343
Page 258 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
13:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138344
Page 259 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138345
Page 260 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138346
Page 261 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020
13:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-16-2020
13:57:36ACV0PFEINFP6000 Monica
CooperData Entry:
Not ApplicableInitial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138347
Page 262 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mcooper)
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138348
Page 263 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-16-2020
13:57:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-16-2020
13:57:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
260125Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138349
Page 264 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
13:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
13:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
18:27:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
13:58:05
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138350
Page 265 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
13:58:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
YES
Date of Collection
:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
18:27:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sample ID
:BPC36
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
18:27:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
BPC361Initial Entry
5.b
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138351
Page 266 of 463
***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: 10131554 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-16-2020
18:27:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sample ID
:BPC36
2Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-16-2020
18:27:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
BPC362Initial Entry
5.c
Date Location User Value Reason
Sep-16-2020
18:27:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Sample ID
:BPC36
3Initial Entry
090177e196ae2f64\Final\Final On: 01-Apr-2021 03:42 (GMT)
FDA-CBER-2021-5683-0138352
Page 2
…[truncated]