Document text
Page 1 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136111
Page 2 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/6/2020
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136112
Page 3 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131089]
2.Birth Date: 1991
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:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0136113
Page 4 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/6/2020
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136114
Page 5 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136115
Page 6 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136116
Page 7 of 225
***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: 10131089 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:[ENVIRONMENTAL ALLERGIES]
Start Date: Feb/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[LEFT TORN LABRUM]
Start Date: Sep/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2011
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[LEFT TORN LABRUM REPAIR]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136117
Page 8 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HISTORY OF SEIZURES]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136118
Page 9 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/6/2020
2.Weight: [52.5]
3.Unit: kg
4.Height: [153.4]
5.Unit: cm
6.Body Mass Index: [22.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136119
Page 10 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/6/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136120
Page 11 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/6/2020
2.Randomization Number: [42820]
3.Randomization Group: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136121
Page 12 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/6/2020
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 [BM8FVD]
5.bSample ID [BM8FVF]
5.cSample ID [BM8FVG]
5.dSample ID [BLCR7R]
5.eSample ID [BLCR7S]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136122
Page 13 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/6/2020
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 [BM8S1B]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136123
Page 14 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/6/2020 11:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136124
Page 15 of 225
***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: 10131089 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
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136125
Page 16 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136126
Page 17 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136127
Page 18 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136128
Page 19 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136129
Page 20 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136130
Page 21 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136131
Page 22 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BN6228]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136132
Page 23 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 13:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136133
Page 24 of 225
***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: 10131089 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/24/2020
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136134
Page 25 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136135
Page 26 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136136
Page 27 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136137
Page 28 of 225
***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: 10131089 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/24/2020
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 [BRG2C0]
5.bSample ID [BRG2C1]
5.cSample ID [BRG2C2]
5.dSample ID [BS6Z4J]
5.eSample ID [BS6Z4K]
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FDA-CBER-2021-5683-0136138
Page 29 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
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FDA-CBER-2021-5683-0136139
Page 30 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
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FDA-CBER-2021-5683-0136140
Page 31 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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 [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136141
Page 32 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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 [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136142
Page 33 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136143
Page 34 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
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FDA-CBER-2021-5683-0136144
Page 35 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136145
Page 36 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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 [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136146
Page 37 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136147
Page 38 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136148
Page 39 of 225
***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: 10131089 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 :Sep/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136149
Page 40 of 225
***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: 10131089 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: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136150
Page 41 of 225
***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: 10131089 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:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136151
Page 42 of 225
***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: 10131089 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 [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136152
Page 43 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Instan
ce
1.ADVERS
E EVENT
1 LEFT ARM DEEP V
EIN THROMBOSIS Dec/20/2020
UNK:UNK YES Repeating
Pages
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136153
Page 44 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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)[LEFT ARM DEEP VEIN THROMBOSIS]
4.Start Date Time: Dec/20/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136154
Page 45 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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:
[UNKOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
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FDA-CBER-2021-5683-0136155
Page 46 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020506317]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136156
Page 47 of 225
***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: 10131089 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
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136157
Page 48 of 225
***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: 10131089 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[ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136158
Page 49 of 225
***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: 10131089 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
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136159
Page 50 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
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FDA-CBER-2021-5683-0136160
Page 51 of 225
***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: 10131089 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
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136161
Page 52 of 225
***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: 10131089 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?
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136162
Page 53 of 225
***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: 10131089 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
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136163
Page 54 of 225
***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: 10131089 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?
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136164
Page 55 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136165
Page 56 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136166
Page 57 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136167
Page 58 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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FDA-CBER-2021-5683-0136168
Page 59 of 225
***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: 10131089 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:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136169
Page 60 of 225
***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: 10131089 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?
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136170
Page 61 of 225
***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: 10131089 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: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136171
Page 62 of 225
***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: 10131089 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: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136172
Page 63 of 225
***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: 10131089 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/22/2021
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136173
Page 64 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136174
Page 65 of 225
***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: 10131089 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/22/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136175
Page 66 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136176
Page 67 of 225
***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: 10131089 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: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136177
Page 68 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136178
Page 69 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/2/2021
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136179
Page 70 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136180
Page 71 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/2/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136181
Page 72 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/2/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136182
Page 73 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
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 [BSLRPC]
5.bSample ID [BSLRPD]
5.cSample ID [BRBRCR]
5.dSample ID [BRBRCS]
5.eSample ID [BRBRCT]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136183
Page 74 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
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 [BRBRVJ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136184
Page 75 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/2/2021 14:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136185
Page 76 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136186
Page 77 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/25/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136187
Page 78 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BR64J1]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136188
Page 79 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 14:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136189
Page 80 of 225
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136190
Page 81 of 225
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136191
Page 82 of 225
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136192
Page 83 of 225
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136193
Page 84 of 225
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136194
Page 85 of 225
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136195
Page 86 of 225
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136196
Page 87 of 225
***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: 10131089 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 Sep/24/2020
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136197
Page 88 of 225
***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: 10131089 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
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136198
Page 89 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Mar-04-2021 06:50:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136199
Page 90 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-06-2020 14:05:55
(UTC-05:00) Eastern Time (US &
Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136200
Page 91 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-03-2021 07:46:17 (UTC-05:00)
Eastern Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136201
Page 92 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Dever Approved Mar-04-2021 06:50:25 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Mar-01-2021 08:57:37 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Feb-04-2021 12:51:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136202
Page 93 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Feb-03-2021 07:45:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Jan-26-2021 06:50:13 (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.
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136203
Page 94 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Scott
Salmon N/A Jan-25-2021 08:22:22 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Jan-21-2021 07:30:02 (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-23-2020 12:55:23 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Oct-05-2020 08:25:40 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136204
Page 95 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Scott
Salmon N/A Sep-24-2020 15:25:19 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Sep-14-2020 22:08:46 (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.
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136205
Page 96 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-06-2020
14:05:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-06-2020
14:05:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136206
Page 97 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-06-2020
14:05:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/6/2020Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136207
Page 98 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-06-2020
14:05:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10131089Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-06-2020
14:05:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1991Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-06-2020
14:05:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0136208
Page 99 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-06-2020
14:05:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-06-2020
14:05:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
WHITEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136209
Page 100 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-06-2020
14:05:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/6/2020Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136210
Page 101 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-06-2020
14:06:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-06-2020
14:06:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-06-2020
14:06:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136211
Page 102 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-06-2020
14:07:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:1
Medical
History
Term:ENVIRON
MENTAL A
LLERGIES
Start Da
te:Feb/UNK/2
020
Ongoing
:YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-06-2020
14:07:11
(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
Aug-06-2020
14:07:11ACV0PFEINFP6000 Matthew
StephensData Entry:
ENVIRONMENTAInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136212
Page 103 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) L ALLERGIES
1.a Start Date:
Date Location User Value Reason
Aug-06-2020
14:07:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Feb/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-06-2020
14:07:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-06-2020
14:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:LEFT TOR
N LABRU
MInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136213
Page 104 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Start Dat
e:Sep/UNK/2
009
Ongoing: NO
End Date:
UNK/U
NK/201
1
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136214
Page 105 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Aug-06-2020
14:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020
14:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFT TORN LAB
RUMInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-06-2020
14:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/UNK/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-06-2020
14:07:40ACV0PFEINFP6000 Matthew
StephensData Entry:
NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136215
Page 106 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) End Date:
UNK/UNK/2011
1.c
Date Location User Value Reason
Aug-06-2020
14:08:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:3
Medical
History
Term:LEFT TORN
LABRUM R
EPAIR
Start D
ate:UNK/UNK/2
011
Ongoin
g:NO
End Date:
UNK/UN
K/2011Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136216
Page 107 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Aug-06-2020
14:08:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020
14:08:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFT TORN LAB
RUM REPAIRInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-06-2020
14:08:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2011Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-06-2020
14:08:47ACV0PFEINFP6000 Matthew
StephensData Entry:
NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136217
Page 108 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) End Date:
UNK/UNK/2011
1.d
Date Location User Value Reason
Aug-06-2020
14:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History
Term:HISTORY
OF SEIZU
RES
Start Dat
e:UNK/UNK/
2004
Ongoing: NO
End Date:
UNK/U
NK/2008Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136218
Page 109 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.d Line/MH Number:
Date Location User Value Reason
Aug-06-2020
14:09:11
(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
Aug-06-2020
14:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
HISTORY OF SEI
ZURESInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-06-2020
14:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2004Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-06-2020
14:09:11ACV0PFEINFP6000 Matthew
StephensData Entry:
NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136219
Page 110 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) End Date:
UNK/UNK/200
8
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136220
Page 111 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
52.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136221
Page 112 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
153.4Initial Entry
5. Unit:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.3Initial Entry
7.a
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:36.9Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136222
Page 113 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136223
Page 114 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Aug-06-2020
14:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136224
Page 115 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/6/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136225
Page 116 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136226
Page 117 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-06-2020
14:09:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136227
Page 118 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-06-2020
15:48:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-06-2020
15:48:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
42820Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136228
Page 119 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020
14:10:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020
14:10:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-06-2020
17:03:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-06-2020
14:10:07
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136229
Page 120 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-06-2020
14:10:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Aug/6/2020Initial Entry
5.a
Date Location User Value Reason
Aug-06-2020
17:03:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BM8FV
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-06-2020
17:03:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8FVDInitial Entry
5.b
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136230
Page 121 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-06-2020
17:04:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BM8FV
FInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-06-2020
17:04:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8FVFInitial Entry
5.c
Date Location User Value Reason
Aug-06-2020
17:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BM8FV
GInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136231
Page 122 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Aug-06-2020
17:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8FVGInitial Entry
5.d
Date Location User Value Reason
Aug-06-2020
17:04:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BLCR7
RInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-06-2020
17:04:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BLCR7RInitial Entry
5.e
Date Location User Value Reason
Aug-06-2020
17:04:30ACV0PFEINFP6000 Matthew
StephensData Entry:
Sample I BLCR7Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136232
Page 123 of 225
***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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: S
5.e Sample ID
Date Location User Value Reason
Aug-06-2020
17:04:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BLCR7SInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136233
Page 124 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020
14:10:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020
14:10:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-06-2020
17:04:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-06-2020
14:10:13
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136234
Page 125 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-06-2020
14:10:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Aug/6/2020Initial Entry
5.a
Date Location User Value Reason
Aug-06-2020
17:04:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BM8S1
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-06-2020
17:04:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8S1BInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136235
Page 126 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136236
Page 127 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/6/2020 11:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136237
Page 128 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-06-2020
14:10:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136238
Page 129 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-06-2020
14:10:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136239
Page 130 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020
14:05:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/27/2020Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136240
Page 131 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:11:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOTranscription
Error
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
2.a
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: F
E
V
E
RInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136241
Page 132 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.a Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-27-2020
14:06:38ACV0PFEINFP6000 Matthew
StephensData Entry:
Symptom:: FAInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136242
Page 133 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) TI
G
U
E
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.b Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2.c
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136243
Page 134 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: HE
A
D
A
C
HE
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:N
OInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136244
Page 135 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.c Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: C
HI
L
L
SInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136245
Page 136 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.d Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-27-2020
14:06:38ACV0PFEINFP6000 Matthew
StephensData Entry:
Symptom:: VOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136246
Page 137 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) MI
TI
NG
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:NO
2.e Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136247
Page 138 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: DI
A
R
R
H
E
A
Were fever or
systemic symp
toms present
on the last da
y the Subject
Diary was co
mpleted?:N
OInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136248
Page 139 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: NEW
OR
WOR
SENE
D M
USCL
E PAI
NInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136249
Page 140 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever
or systemic
symptoms
present on
the last day
the Subject
Diary was
completed?
:NO
2.g Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEW OR WORSE
NED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136250
Page 141 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: NEW
OR
WOR
SEN
ED J
OINT
PAIN
Were fever
or systemic
symptoms
present on t
he last day
the Subject
Diary was c
ompleted?:NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136251
Page 142 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h Symptom:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEW OR WORSE
NED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136252
Page 143 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Injection Site
Reaction::R
E
D
N
ES
S
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
REDNESSInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136253
Page 144 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136254
Page 145 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Injection Sit
e Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136255
Page 146 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were injecti
on site reacti
ons present
on the last d
ay the Subje
ct Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
PAIN AT INJECTI
ON SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020
14:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136256
Page 147 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020
14:06:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/27/2020Initial Entry
2.a
Date Location User Value Reason
Aug-27-2020
14:06:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:36.5
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-27-2020
14:06:53
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136257
Page 148 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Aug-27-2020
14:06:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-27-2020
14:06:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-27-2020
14:06:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136258
Page 149 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136259
Page 150 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136260
Page 151 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020
14:07:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136261
Page 152 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
14:07:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
14:07:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
17:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-27-2020
14:07:11
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136262
Page 153 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
14:07:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020
17:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BN622
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020
17:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BN6228Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136263
Page 154 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136264
Page 155 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/27/2020 13:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136265
Page 156 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-27-2020
14:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136266
Page 157 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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-24-2020
15:25:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/24/2020Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136267
Page 158 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136268
Page 159 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136269
Page 160 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.b Symptom:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136270
Page 161 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-24-2020
15:26:14ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Symptom:: CInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136271
Page 162 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136272
Page 163 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136273
Page 164 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136274
Page 165 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136275
Page 166 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
2.g Symptom:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-24-2020 ACV0PFEINFP6000 Scott Salmon Data Entry: Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136276
Page 167 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.ssalmon) Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136277
Page 168 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h Symptom:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136278
Page 169 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Injection Site R
eaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
REDNESSInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136279
Page 170 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136280
Page 171 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136281
Page 172 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020
15:26:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136282
Page 173 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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-24-2020
15:26:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020
15:26:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020
07:59:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-25-2020
03:46:18
(UTC-05:00)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136283
Page 174 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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-24-2020
15:26:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-24-2020
15:26:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
07:59:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRG2C
0Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136284
Page 175 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-25-2020
07:59:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BRG2C0Initial Entry
5.b
Date Location User Value Reason
Sep-25-2020
07:59:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRG2C
1Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-25-2020
07:59:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BRG2C1Initial Entry
5.c
Date Location User Value Reason
Sep-25-2020
07:59:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRG2C
2Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136285
Page 176 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Sep-25-2020
07:59:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BRG2C2Initial Entry
5.d
Date Location User Value Reason
Sep-25-2020
08:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BS6Z4
JInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-25-2020
08:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BS6Z4JInitial Entry
5.e
Date Location User Value Reason
Sep-25-2020
08:18:10ACV0PFEINFP6000 Matthew
StephensData Entry:
Sample I BS6Z4Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136286
Page 177 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: K
5.e Sample ID
Date Location User Value Reason
Sep-25-2020
08:18:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BS6Z4KInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136287
Page 178 of 225
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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-24-2020
15:27:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020
15:27:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020
15:27:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136288
Page 179 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Form Created
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136289
Page 180 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-23-2021
13:16:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-11-2021
16:21:51
(UTC-05:00)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 1: Answere
dUPDATED
PER CRC
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136290
Page 181 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)
Feb-02-2021
14:27:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical Please
submit a SAE
safety
followup
specifying how
long subject's
presenting Lt
arm pain,
swelling,
discoloration
was present
prior to ER
visit on
20Dec20
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFT ARM DEE
P VEIN THROM
BOSISInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-23-2021
13:12:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-11-2021
16:24:01ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 1: Answer
edSAE AND AE
CRF ARE
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136291
Page 182 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)CURRENTLY
ONGOING.
Feb-02-2021
14:26:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical
Followup -
please review
for End date,
and report to
both SAE and
on AE CRF if
available
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Dec/20/2020 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
3Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136292
Page 183 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Jan-20-2021
21:55:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Jan-18-2021
14:58:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Monica Cooper
(pfe.mcooper)Query 2: Answer
edFOLLOW UP
SAE FORM
SUBMITTED;
CONFIRMED
NO HOSPITAL
COVID TEST
PERFORMED
Jan-11-2021
21:16:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Reissue
d:OpenedClinical – Thank
you. If NO
hospital COVID
test was
performed is
known, please
submit this
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136293
Page 184 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
information on a
follow-up SAE
form, as
pertinent
information for
this trial.
Dec-31-2020
02:18:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-28-2020
09:04:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 2: Answer
edPER CRC NO
COVID TEST
WAS
PERFORMED
PER MEDICAL
RECORDS
RECIEVED.
Dec-23-2020
15:15:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical COVID
test status
(yes/no) during
Hospitalization
was not reported
in the SAE.
Please submit a
follow-up SAE
form
[#2020506317]
to document if
COVID testing
was performed
(YES/NO or info
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136294
Page 185 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
not available)
and if yes, the
date and results.
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candid
ateFor AE LEFT
ARM DEEP
VEIN
THROMBOSIS:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in
death?
NO
Did this serious
event require oInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136295
Page 186 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
r prolong hospi
talization?
YES
Did this serious
event result in
persistent or si
gnificant disabi
lity/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medicall
y important ser
ious 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.
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136296
Page 187 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021
19:02:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Jan-12-2021
20:49:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dTranscription
Error
Jan-12-2021
20:49:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHER
If Other, speci
fy:
UNKOWNTranscription
Error
Jan-11-2021
21:19:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Reissued
:OpenedClinical Thank
you. If no
Other reason
for Lt. arm
DVT is known,
then 'Other'
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136297
Page 188 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
reasons is
Unknown
Dec-28-2020
09:16:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 1: Answere
dPER CRC,
NOTHING IN
MEDICAL
RECORDS OF
OTHER
ONSET
CONDITION
FOR DVT.
Dec-23-2020
15:17:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical Other
condition
which might be
related to onset
of DVT cannot
be DVT. SAE
report does
state that Yaz
was
discontinued as
a result of this
SAE; please
review and
update OTHER
relationship, if
appropriate
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136298
Page 189 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
OTHER
If Other, speci
fy:
DEEP VEI
N THROM
BOSIS
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-23-2020 ACV0PFEINFP6000 Matthew Data Entry: Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136299
Page 190 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)Stephens
(pfe.mstephens)NO
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
RECOVERING/RE
SOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-23-2020
12:55:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-31-2020
02:18:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020506317Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136300
Page 191 of 225
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021
08:22:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Jan/22/2021Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136301
Page 192 of 225
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-25-2021
08:22:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Participant is willing
to return for Vaccinat
ion 3
Participant is:
eligible per local/
national recomme
ndations and confi
rmed to have recei
ved only placebo
at Vaccination 1/2Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136302
Page 193 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-25-2021
08:22:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Jan/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-25-2021
08:22:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136303
Page 194 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10131089 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
Feb-03-2021
07:45:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/2/2021Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136304
Page 195 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
Feb-03-2021
07:46:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/2/2021Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136305
Page 196 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
Feb-03-2021
07:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/2/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-03-2021
07:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-03-2021
07:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136306
Page 197 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/2/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136307
Page 198 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136308
Page 199 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-03-2021
07:47:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136309
Page 200 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10131089 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
Feb-03-2021
07:47:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021
07:47:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021
09:07:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-03-2021
07:47:34
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136310
Page 201 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10131089 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.
Feb-03-2021
07:47:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Feb/2/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021
09:07:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BSLRP
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021
09:07:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BSLRPCInitial Entry
5.b
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136311
Page 202 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Feb-03-2021
09:07:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BSLRP
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-03-2021
09:07:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BSLRPDInitial Entry
5.c
Date Location User Value Reason
Feb-03-2021
09:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BRBRC
RInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136312
Page 203 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Feb-03-2021
09:07:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BRBRCRInitial Entry
5.d
Date Location User Value Reason
Feb-03-2021
09:07:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BRBRC
SInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-03-2021
09:07:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BRBRCSInitial Entry
5.e
Date Location User Value Reason
Feb-03-2021
09:07:44ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I BRBRCInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136313
Page 204 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)D: T
5.e Sample ID
Date Location User Value Reason
Feb-03-2021
09:07:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BRBRCTInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136314
Page 205 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
Feb-03-2021
07:47:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021
07:47:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021
09:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-03-2021
07:47:48
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136315
Page 206 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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.
Feb-03-2021
07:47:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Feb/2/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021
09:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BRBRV
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021
09:08:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BRBRVJInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136316
Page 207 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136317
Page 208 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/2/2021 14:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136318
Page 209 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
8. Actual Dose:
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-03-2021
07:49:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-03-2021
07:49:20ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136319
Page 210 of 225
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136320
Page 211 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10131089 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
Mar-01-2021
08:57:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/25/2021Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136321
Page 212 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/25/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136322
Page 213 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136323
Page 214 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Mar-01-2021
08:57:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136324
Page 215 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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
Mar-01-2021
08:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
08:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021
15:20:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-02-2021
04:53:41
(UTC-05:00)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136325
Page 216 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 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.
Mar-01-2021
08:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
08:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021
15:20:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BR64J
1Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136326
Page 217 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-02-2021
15:20:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BR64J1Initial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136327
Page 218 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136328
Page 219 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/25/2021 14:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136329
Page 220 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
8. Actual Dose:
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-01-2021
08:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Mar-01-2021
08:58:37ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f56\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0136330
Page 221 of 225
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
…[truncated]