Document text
Page 1 of 179
***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: 10131084 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
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FDA-CBER-2021-5683-0135932
Page 2 of 179
***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: 10131084 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/5/2020
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135933
Page 3 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131084]
2.Birth Date: 1971
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135934
Page 4 of 179
***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: 10131084 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/5/2020
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135935
Page 5 of 179
***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: 10131084 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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135936
Page 6 of 179
***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: 10131084 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/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135937
Page 7 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT RENAL STENT INSERTION]
Start Date: Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/2020
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135938
Page 8 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [57.6]
3.Unit: kg
4.Height: [157.0]
5.Unit: cm
6.Body Mass Index: [23.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [35.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135939
Page 9 of 179
***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: 10131084 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/5/2020
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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135940
Page 10 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [42812]
3.Randomization Group: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135941
Page 11 of 179
***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: 10131084 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/5/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8FV3]
5.bSample ID [BM8FV4]
5.cSample ID [BM8FV5]
5.dSample ID [BLCR7J]
5.eSample ID [BLCR7K]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135942
Page 12 of 179
***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: 10131084 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/5/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8S17]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135943
Page 13 of 179
***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: 10131084 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/5/2020 10:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135944
Page 14 of 179
***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: 10131084 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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135945
Page 15 of 179
***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: 10131084 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/26/2020
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135946
Page 16 of 179
***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: 10131084 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
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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135947
Page 17 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135948
Page 18 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135949
Page 19 of 179
***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: 10131084 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/26/2020
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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135950
Page 20 of 179
***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: 10131084 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/26/2020
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 [BN620W]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135951
Page 21 of 179
***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: 10131084 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/26/2020 15:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135952
Page 22 of 179
***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: 10131084 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/30/2020
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135953
Page 23 of 179
***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: 10131084 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?YES
Ongoing?
NO
Stop Date:
Sep/1/2020
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
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Sep/1/2020
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135954
Page 24 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Sep/1/2020
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Sep/1/2020
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
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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135955
Page 25 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135956
Page 26 of 179
***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: 10131084 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/30/2020
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 [BRG2HL]
5.bSample ID [BRG2HM]
5.cSample ID [BRG2HN]
5.dSample ID [BS6Z7L]
5.eSample ID [BS6Z7M]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135957
Page 27 of 179
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135958
Page 28 of 179
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BV09WG]
5.bSample ID [BV09WH]
5.cSample ID [BV09WJ]
5.dSample ID [BS49CG]
5.eSample ID [BS49CH]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135959
Page 29 of 179
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135960
Page 30 of 179
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135961
Page 31 of 179
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135962
Page 32 of 179
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135963
Page 33 of 179
***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: 10131084 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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135964
Page 34 of 179
***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: 10131084 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: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135965
Page 35 of 179
***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: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135966
Page 36 of 179
***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: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135967
Page 37 of 179
***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: 10131084 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?
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135968
Page 38 of 179
***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: 10131084 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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135969
Page 39 of 179
***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: 10131084 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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135970
Page 40 of 179
***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: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135971
Page 41 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/04/2020Form: 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: 10131084 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/4/2020
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135972
Page 42 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/04/2020Form: UNPLANNED VISIT
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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135973
Page 43 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/04/2020Form: CONTACT OUTCOME - UNPLANNED
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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/4/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [SUBJECT WAS CONTACTED TODAY 04SEP2020. SUBJECT WENT TO
ER FOR VOMITING AND ABDOMINAL PAIN. ON 03SEP2020
SUBJECT DEVELOPED FEVER AND AGAIN WENT TO ER. SUBJECT
WAS TOLD SHE HAS A URINARY TRACT INFECTION]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135974
Page 44 of 179
***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: 10131084 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/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135975
Page 45 of 179
***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: 10131084 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: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135976
Page 46 of 179
***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: 10131084 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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135977
Page 47 of 179
***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: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135978
Page 48 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 OBSTRUCTED RENA
L STENT (ARTERY) Sep/1/2020
UNK:UNK YES Repeating
Pages
2. DELETED ADVERSE
EVENT 2 URINARY TRACT INF
ECTION Sep/3/2020 2
1:00 YES Repeating
Pages
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135979
Page 49 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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)[OBSTRUCTED RENAL STENT (ARTERY)]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135980
Page 50 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[RENAL STENT]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020345173]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135981
Page 51 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[URINARY TRACT INFECTION ]
4.Start Date Time: Sep/3/2020 21:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135982
Page 52 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[URINARY TRACT INFECTION ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020345173 ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135983
Page 53 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135984
Page 54 of 179
***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: 10131084 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[ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135985
Page 55 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135986
Page 56 of 179
***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: 10131084 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: //
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135987
Page 57 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135988
Page 58 of 179
***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: 10131084 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?
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135989
Page 59 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135990
Page 60 of 179
***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: 10131084 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?
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135991
Page 61 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135992
Page 62 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135993
Page 63 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135994
Page 64 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135995
Page 65 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135996
Page 66 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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?
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135997
Page 67 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135998
Page 68 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0135999
Page 69 of 179
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136000
Page 70 of 179
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136001
Page 71 of 179
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136002
Page 72 of 179
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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 [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136003
Page 73 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136004
Page 74 of 179
***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: 10131084 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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136005
Page 75 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/22/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136006
Page 76 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136007
Page 77 of 179
***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: 10131084 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: [ ]
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136008
Page 78 of 179
***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: 10131084 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/30/2020
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136009
Page 79 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10131084 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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136010
Page 80 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10131084 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 06:47:57 (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.
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136011
Page 81 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-05-2020 12:41:49 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136012
Page 82 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-04-2020 13:24:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe.mstephens)
FormAug-05-2020 12:42:24 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe.mstephens)NO MEDICAL HISTORY REPORTED
Not Applicable
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136013
Page 83 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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 06:47:57 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Scott Salmon N/A Feb-25-2021 14:27:10 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia Brown Approved Feb-25-2021 13:27:20 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaBrown, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Monica
Cooper N/A Feb-17-2021 16:10:51 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136014
Page 84 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
N/A
Michael Dever Approved Oct-12-2020 08:38:41 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Ricell Ann
Piojo N/A Oct-08-2020 22:47:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Oct-08-2020 16:00:49 (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 Oct-08-2020 08:43:25 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Oct-05-2020 08:24:07 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136015
Page 85 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 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.
Rebecca
Klipper N/A Sep-21-2020 16:26:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Sep-14-2020 22:06:57 (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.
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136016
Page 86 of 179
***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: 10131084 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-05-2020 12:41:11
(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-05-2020 12:41:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136017
Page 87 of 179
***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: 10131084 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-05-2020 12:41:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/5/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136018
Page 88 of 179
***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: 10131084 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-05-2020 12:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10131084Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-05-2020 12:41:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1971Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-05-2020 12:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-05-2020 12:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-05-2020 12:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
WHITEInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
(b) (6)
FDA-CBER-2021-5683-0136019
Page 89 of 179
***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: 10131084 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-05-2020 12:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/5/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136020
Page 90 of 179
***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: 10131084 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-05-2020 12:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-05-2020 12:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-05-2020 12:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136021
Page 91 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020 10:27:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Line/MH
Number:1
Medical
History T
erm:RIGHT RENAL
STENT INSERT
ION
Start Dat
e:Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/202
0Transcription
Error
Sep-08-2020 07:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Line/MH
Number:1
Medical
History T
erm:RIGHT RENTA
L STENT INSER
TION
Start Dat
e:Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/202
0Transcription
Error
Sep-04-2020 13:25:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:RIGHT RENT
AL STENT
Start Date: Feb/UNK/202
0Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136022
Page 92 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Date:
Feb/UNK/2
020
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020 13:25:21
(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 ValueReason
Sep-10-2020
19:09:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle
(pfe.PFETMS)Query
2: Clo
sedDiscrepancy
has been
closed.
Sep-10-2020
10:27:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
2: An
swere
dTranscription
Error
Sep-10-2020
10:27:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew Stephens
(pfe.mstephens)Data
Entry
:
RIGH
T RE
NAL
STEN
T INS
ERTI
ONTranscription
Error
Sep-10-2020
10:20:33ACV0PFEINFP6000 Jeffrey Signora
TMSQUERYQuery
2: ReiPlease review
the spelling
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136023
Page 93 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US &
Canada)(pfe.signoj01_tmsquery) ssued:
Open
edof "RENAL"
and make the
appropriate
update.
Sep-08-2020
09:53:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew Stephens
(pfe.mstephens)Query
2: An
swere
dChanged data
per query
Sep-08-2020
09:46:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle
(pfe.PFETMS)Query
2: Op
enedClarify
RIGHT
RENTAL
STENT
INSERTION
as
follows...Are
you reporting
RIGHT
RENAL
STENT
INSERTION?
If so, update
the verbatim
term as such.
Otherwise
clarify and
edit the term.
Thank you.
Sep-08-2020
08:34:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy
has been
closed.
Sep-08-2020
07:52:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: An
swere
dTranscription
Error
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136024
Page 94 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-08-2020
07:52:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew Stephens
(pfe.mstephens)Data
Entry
:
RIGH
T RE
NTA
L ST
ENT I
NSER
TIONTranscription
Error
Sep-05-2020
05:08:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle
(pfe.PFETMS)Query
1: Op
enedClarify
RIGHT
RENTAL
STENT as
follows...The
term is
unclear. Are
you reporting
RIGHT
RENAL
ARTERY
STENT
INSERTION?
REMOVAL?
INFECTION
OF? Other? If
so, edit the
term as such.
Otherwise
clarify and
edit the term
as
appropriate.
Thank you.
Sep-04-2020
13:25:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Matthew Stephens
(pfe.mstephens)Data
Entry
:
RIGH
T RE
NTA
L ST
ENTInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136025
Page 95 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 13:25:21
(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
Sep-04-2020 13:25:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NO
End Date:
Feb/UNK/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136026
Page 96 of 179
***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: 10131084 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-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
57.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
157.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-05-2020 12:42:50
(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
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136027
Page 97 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.4Initial Entry
7.a
Date Location User Value Reason
Aug-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Identifi
er::1
Temperature: 35.7
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-05-2020 12:42:50
(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
04:07:15 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Site confirmed data
is correct.
Aug-05-2020
12:43:47 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered CORRECT AS
RECORDED PER
SOURCE. WITHIN
NORMAL LIMITS
PER
INVESTIGATOR.
Aug-05-2020
12:42:50 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 35.7 C
is outside of Normal
Range 36.1 - 37.5 C.
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136028
Page 98 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-05-2020
12:42:50 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
35.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-05-2020 12:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136029
Page 99 of 179
***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: 10131084 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-05-2020 12:43:14
(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-05-2020 12:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-05-2020 12:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-05-2020 12:43:14
(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-05-2020 12:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136030
Page 100 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-05-2020 12:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-05-2020 12:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-05-2020 12:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-05-2020 12:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136031
Page 101 of 179
***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: 10131084 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-05-2020 13:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-05-2020 13:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
42812Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136032
Page 102 of 179
***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: 10131084 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-05-2020 12:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 12:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 14:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 12:43:55
(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.
Aug-05-2020 12:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136033
Page 103 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-05-2020 14:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BM8FV3Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 14:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8FV3Initial Entry
5.b
Date Location User Value Reason
Aug-05-2020 14:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BM8FV4Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-05-2020 14:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8FV4Initial Entry
5.c
Date Location User Value Reason
Aug-05-2020 14:14:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BM8FV5Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-05-2020 14:14:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8FV5Initial Entry
5.d
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136034
Page 104 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-05-2020 14:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BLCR7JInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-05-2020 14:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BLCR7JInitial Entry
5.e
Date Location User Value Reason
Aug-05-2020 14:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BLCR7KInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-05-2020 14:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BLCR7KInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136035
Page 105 of 179
***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: 10131084 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-05-2020 12:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 12:44:02
(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-05-2020 14:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 12:44:02
(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.
Aug-05-2020 12:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136036
Page 106 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-05-2020 14:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BM8S17Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 14:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BM8S17Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136037
Page 107 of 179
***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: 10131084 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-05-2020 12:44:38
(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-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/5/2020 10:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136038
Page 108 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-05-2020 12:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136039
Page 109 of 179
***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: 10131084 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-05-2020 12:44:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136040
Page 110 of 179
***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: 10131084 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-26-2020 15:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136041
Page 111 of 179
***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: 10131084 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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136042
Page 112 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136043
Page 113 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.c Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136044
Page 114 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.e
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136045
Page 115 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE
PAIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136046
Page 116 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.g Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pre
sent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136047
Page 117 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h Symptom:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NEW OR WORSENED JOIN
T 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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-26-2020 15:56:30
(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
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Injection Site Reaction:
:RE
DN
ES
S
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136048
Page 118 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Injection Site Reaction
::SW
ELL
ING
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136049
Page 119 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site r
eactions present on t
he last day the Subj
ect Diary was compl
eted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136050
Page 120 of 179
***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: 10131084 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-26-2020 15:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Aug/26/2020Initial Entry
2.a
Date Location User Value Reason
Aug-26-2020 15:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Record Identifie
r::1
Temperature: 37.0
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 15:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-26-2020 15:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-26-2020 15:55:00 ACV0PFEINFP6000 Monica Data Entry: Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136051
Page 121 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)Cooper
(pfe mcooper)C
2.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 15:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136052
Page 122 of 179
***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: 10131084 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-26-2020 15:55:30
(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-26-2020 15:55:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-26-2020 15:55:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Aug/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-26-2020 15:55:30
(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-26-2020 15:55:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136053
Page 123 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-26-2020 15:55:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-26-2020 15:55:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020 15:55:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Aug-26-2020 15:55:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136054
Page 124 of 179
***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: 10131084 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-26-2020 15:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 15:55:42
(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 07:52:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 01:02:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ankita Thakur
(pfe.thakua20)Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 15:55:42
(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.
Aug-26-2020 15:55:42
(UTC-05:00) EasternACV0PFEINFP6000 Monica
CooperData Entry:
YESInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136055
Page 125 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.mcooper) Date of Collection:
Aug/26/2020
5.a
Date Location User Value Reason
Aug-27-2020 07:52:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample ID: BN620WInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 07:52:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BN620WInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136056
Page 126 of 179
***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: 10131084 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-26-2020 15:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 15:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 15:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 06:59:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swapna
Varikuti
(pfe.variks)Query 1: Closed UNPL updated
Sep-04-2020 10:29:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered UNPLANNED
VISIT HAS BEEN
ADDED.
Sep-03-2020 04:02:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swapna
Varikuti
(pfe.variks)Query 1: Opened PDQ: Subject has
reported severe
Vomiting Severity
in eDiary data on
1Sep2020. Please
confirm if an
UNPLANNED
contact was made
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136057
Page 127 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
and update the data
under UNPL visit
else clarify.
Aug-26-2020 15:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica Cooper
(pfe mcooper)Data Entry:
Aug/26/2020 15:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 15:55:59
(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-26-2020 15:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020 15:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020 15:55:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-26-2020 15:55:59 ACV0PFEINFP6000 Monica Data Entry: Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136058
Page 128 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)Cooper
(pfe mcooper)YES
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136059
Page 129 of 179
***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: 10131084 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-30-2020 16:39:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sep/30/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136060
Page 130 of 179
***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: 10131084 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-30-2020 16:40:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/1/2020Transcription
Error
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(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?
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136061
Page 131 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(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
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Symptom:: HE
AD
ACInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136062
Page 132 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
HE
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NO
2.c Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(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
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 16:41:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: CHILLSTranscription
Error
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136063
Page 133 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:YES
Ongoin
g?
NO
Stop
Dat
e:
Se
p/
1/
20
20
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136064
Page 134 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.d Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(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
Sep-30-2020 16:41:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/1/2020Transcription
Error
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-30-2020 16:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: VOMITI
NGTranscription
Error
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136065
Page 135 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:YES
Ongoin
g?
NO
Stop
Dat
e:
Se
p/
1/
20
20
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136066
Page 136 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.e Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(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
Sep-30-2020 16:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/1/2020Transcription
Error
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020 16:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: DIARR
HEATranscription
Error
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136067
Page 137 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:YES
Ongoin
g?
NO
Stop
Dat
e:
Se
p/
1/
20
20
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136068
Page 138 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(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
Sep-30-2020 16:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/1/2020Transcription
Error
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136069
Page 139 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.g Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NEW OR WORSENED MU
SCLE 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-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed
?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136070
Page 140 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h Symptom:
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NEW OR WORSENED JOI
NT 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-30-2020 16:39:51
(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
Sep-30-2020 16:39:51
(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
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Injection Site Reaction
::RE
DN
ES
S
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136071
Page 141 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 16:39:51
(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
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136072
Page 142 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Injection Site React
ion::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site
reactions present o
n the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 16:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136073
Page 143 of 179
***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: 10131084 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-30-2020 16:40:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 16:40:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 08:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-01-2020 05:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-30-2020 16:40:01
(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-30-2020 16:40:01
(UTC-05:00) EasternACV0PFEINFP6000 Matthew
StephensData Entry:
YESInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136074
Page 144 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe mstephens) Date of Collection:
Sep/30/2020
5.a
Date Location User Value Reason
Oct-01-2020 08:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRG2HLInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 08:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BRG2HLInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020 08:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRG2HMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020 08:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BRG2HMInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 08:03:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BRG2HNInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136075
Page 145 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-01-2020 08:03:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BRG2HNInitial Entry
5.d
Date Location User Value Reason
Oct-01-2020 08:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BS6Z7LInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-01-2020 08:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BS6Z7LInitial Entry
5.e
Date Location User Value Reason
Oct-01-2020 08:04:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BS6Z7MInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-01-2020 08:04:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BS6Z7MInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136076
Page 146 of 179
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10131084 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-24-2021 16:08:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/24/2021Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136077
Page 147 of 179
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10131084 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-24-2021 16:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021 16:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-25-2021 14:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-25-2021 06:25:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-24-2021 16:08:23
(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.
Feb-24-2021 16:08:23
(UTC-05:00) EasternACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YESInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136078
Page 148 of 179
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Date of Collection:
Feb/24/2021
5.a
Date Location User Value Reason
Feb-25-2021 14:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID: BV09WGInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-25-2021 14:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BV09WGInitial Entry
5.b
Date Location User Value Reason
Feb-25-2021 14:27:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID: BV09WHInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-25-2021 14:27:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BV09WHInitial Entry
5.c
Date Location User Value Reason
Feb-25-2021 14:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID: BV09WJInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136079
Page 149 of 179
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Feb-25-2021 14:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BV09WJInitial Entry
5.d
Date Location User Value Reason
Feb-25-2021 14:27:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID: BS49CGInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-25-2021 14:27:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BS49CGInitial Entry
5.e
Date Location User Value Reason
Feb-25-2021 14:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID: BS49CHInitial Entry
5.e Sample ID
Date Location User Value Reason
Feb-25-2021 14:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BS49CHInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136080
Page 150 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/04/2020Form: 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: 10131084 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-04-2020 10:26:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sep/4/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136081
Page 151 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/04/2020Form: UNPLANNED VISIT - 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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Assessments
Date Location User Value Reason
Sep-04-2020 10:29:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 10:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome
is ticked however
'CONTACT
OUTCOME' form
is not entered.
Please review and
update as
appropriate.
Sep-04-2020 10:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136082
Page 152 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/04/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-04-2020 10:29:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-04-2020 10:29:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Contact:
Sep/4/2020
Contact Outcome:
VISIT NOT REQUIRED,
INVESTIGATOR DECISI
ONInitial Entry
3. Comments:
Date Location User Value Reason
Sep-04-2020 10:29:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
SUBJECT WAS CONTACTE
D TODAY 04SEP2020. SUB
JECT WENT TO ER FOR V
OMITING AND ABDOMIN
AL PAIN. ON 03SEP2020 S
UBJECT DEVELOPED FEV
ER AND AGAIN WENT TO
ER. SUBJECT WAS TOLD S
HE HAS A URINARY TRA
CT INFECTIONInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136083
Page 153 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-02-2020 08:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 08:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 08:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136084
Page 154 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Form Created
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136085
Page 155 of 179
***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: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-30-2020 16:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Form Deleted Changed
Information
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Form Created
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136086
Page 156 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-02-2020 08:45:24
(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
Oct-27-2020
21:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies query
Oct-27-2020
07:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 3: Answered PER AE TERM STENT
WAS LOCATED IN
ARTERY.
Oct-26-2020
11:25:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Opened Clinical - please
confirm if this renal
stent (which became
'clogged') was located in
the renal artery, in the
ureter, or in other
location.
Oct-08-2020
22:49:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 2: Closed Response satisfies query
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136087
Page 157 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-08-2020
08:43:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 2: Answered Changed data per query
Oct-08-2020
06:52:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 2: Reissued:Open
edSAE RECON 3:The
event term was updated
in Safety database to
'obstructed renal artery
stent' as SERIOUS
adverse event. However,
in AE CRF seriousness
was answered NO.
please confirm if it
should be updated to
YES. Otherwise submit
a follow up AEM form.
Oct-07-2020
07:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 2: Answered CRC WILL UPDATE
WITH FOLLOW UP
Oct-07-2020
06:12:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 2: Reissued:Open
edSAE RECON 2: Per
previous query response
'PER CRC, SUBJECT
DID NOT HAVE A
URINARY TRACT
INFECTION. Please
submit a follow up
AEM form to
downgrade event in
Safety database and
include the clarification
Oct-06-2020
07:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 2: Reissued:Candi
dateFor PSSR review
Oct-05-2020
08:49:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 2: Answered Correct as recorded. AE
not serious.
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136088
Page 158 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-03-2020
07:29:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 2: Reissued:Open
edSAE RECON 1: The
question 'Is the adverse
event serious?' for
OBSTRUCTED
RENAL STENT
(ARTERY) was
answered to No, please
confirm if this should be
updated to yes per query
response
below.Also,follow up
AEM form needs to be
submitted.
Oct-02-2020
09:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 2: Answered PER CRC, SUBJECT
DID NOT HAVE A
URINARY TRACT
INFECTION. MORE
INFORMATION WAS
OBTAINED AND SAE
WAS UPDATED TO
OBSTRUCTED
RENAL STENT
ARTERY.
Oct-02-2020
09:00:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 2: Opened SAE RECON:
AER#2020345173,
AE#2 'urinary tract
infection' was
inactivated. Please
clarify why the event
term was removed
completed as it should
at a minimum be
retained as a
non-serious event and
clarified in a follow-up
SAE form.
Sep-30-2020
16:43:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
OBSTRUCTED RENAL
STENT (ARTERY)Changed Information
Sep-04-2020 ACV0PFEINFP6000 Sian Jones Query 1: Closed Response satisfies query
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136089
Page 159 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
16:03:19
(UTC-05:00) Eastern
Time (US & Canada)(pfe.jones111)
Sep-04-2020
13:26:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered RIGHT RENTAL
STENT HAS BEEN
ADDED TO
MEDICAL HISTORY.
AE OF
OBSTRUCTION
RENAL STENT IS
NOT AN SAE.
SUBJECT WAS NOT
HOSPITALIZED.
PLEASE SEE NEW AE
OF URINARY TRACT
INFECTION.
Sep-04-2020
12:38:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Reissued:Open
edclinical: CRF unfrozen.
Please advise whether
patient hospitalized or
not and on any medical
treatment. Thanks
Sep-04-2020
10:40:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered PLEASE UNLOCK
MEDICAL HISTORY
SO PAGE CAN BE
UPDATED.
Sep-04-2020
10:38:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Reissued:Open
edclinical: do not see
update on MedHx CRF.
Pls also address other
questions in prior query
re
treatment/hospitalisaton.
Thanks
Sep-04-2020
08:54:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered MEDICAL HISTORY
UPDATED.
Sep-03-2020
14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Opened clinical: pls confirm
does not meet SAE
requirements eg
hospitalization, and no
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136090
Page 160 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
medication or other
treatment provided. If pt
with prior hx of stent
please update MedHx
CRF with relevant
information. Thanks
Sep-02-2020
08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
OBSTRUCTED RENAL
STENTInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020 09:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 3: Closed Per latest Argus
database
information, onset
date updated to Sep
1. Issue resolved
Oct-11-2020 09:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 3: Reissued:Candida
tePending SDB update
Oct-09-2020 15:32:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rebecca
Klipper
(pfe.rklipper)Query 3: Answered Updated report has
been submitted to
safety.
Oct-09-2020 10:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gladys Noi
(pfe.noig)Query 3: Reissued:Opened SAE RECON 1: Per
query response, If
safety update is
required, please
submit a follow-up
SAE form
Oct-09-2020 09:31:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 3: Answered PER SOURCE
START DATE IS
01/SEP/2020.
Oct-08-2020 23:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 3: Opened SAE RECON:
AER#2020345173
Oct-08-2020 00:04:27 ACV0PFEINFP6000 Kathryn Sewell Query 2: Closed Response satisfies
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136091
Page 161 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)(pfe.sewelk02) query
Oct-07-2020 13:56:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 2: Answered CRC HAS
UPDATED
SAFETY FOLLOW
UP.
Oct-07-2020 12:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Reissued:Opened CLINICAL SAE
narrative for UTI
still states ER visit
for vomiting due to
obstructed renal
stent was on
8/31/20; however
subject eDIARY
states ER visit was
on 9/1/20, the AE
start date. Please
hold query open
until SAE safety
update/clarification
submitted
Oct-06-2020 09:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 2: Answered CRC WILL
COMPLETE
FOLLOW UP.
Oct-05-2020 16:52:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL SAE
narrative for UTI
still states ER visit
for vomiting due to
obstructed renal
stent was on
8/31/20; however
subject eDIARY
states ER visit was
on 9/1/20, the AE
start date. Please
submit SAE safety
update with 9/1 for
ER visit, if correct
Sep-22-2020 11:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136092
Page 162 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-21-2020 16:26:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-21-2020 16:26:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rebecca
Klipper
(pfe.rklipper)Data Entry:
Sep/1/2020 UNK:UNKNew Information
Sep-11-2020 09:31:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL SAE
narrative for UTI
states ER visit for
vomiting due to
obstructed renal
stent was on
8/31/20; however
subject eDIARY
states ER visit was
on 9/1/20 (both
unknown times).
Please confirm date
for ER visit for this
event and update if
necessary.
Sep-04-2020 10:30:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Aug/31/2020 UNK:UNKTranscription Error
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) EasternACV0PFEINFP6000 Matthew
StephensData Entry:
2Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136093
Page 163 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe mstephens)
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
Dec-01-2020 18:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Nov-30-2020
13:41:52 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 3: Answered PER CRC,
INFORMATION IS
IN THE
NARRATIVE.
Nov-24-2020
23:17:41 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Reissued:Opened Clinical Thank you;
however that most
recent submission on
14Oct20 does not
contain information
concerning any
COVID test
performed
(YES/NO) during
the hospitalization.
Please submit this
information, and if
Yes, include
date/result.
Nov-24-2020
10:22:31 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 3: Answered Form submitted on
10/14/20.
Nov-23-2020
17:28:06 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Opened Clinical - Followup /
COVID testing in
Hospital has not
been reported in the
SAE. Please submit
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136094
Page 164 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
a follow-up SAE
[#2020345173]form
to provide whether
COVID testing was
performed (yes/no)
and if yes, the date
& results.
Oct-27-2020 22:00:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Query closed; will
follow for SAE
update with
requested COVID
test info
Oct-27-2020 07:46:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 2: Answered CRC WILL
UPDATE WITH
FOLLOW UP SAE
FORM.
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136095
Page 165 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
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
Oct-22-2020 22:13:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical - COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE
form
[#2020345173] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-08-2020 22:47:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 08:43:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
OBSTRUCTED
RENAL STENT
(ARTERY):
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Oct-08-2020 08:43:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?Transcription Error
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136096
Page 166 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
NO
Did this serious event resu
lt in death?
NO
Did this serious event req
uire or prolong hospitaliza
tion?
YES
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically important
serious event
NO
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
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
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136097
Page 167 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
RENAL STENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-02-2020 08:45:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136098
Page 168 of 179
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-02-2020 08:45:24
(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
Oct-08-2020 22:47:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020345173Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136099
Page 169 of 179
***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, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
URINARY TRACT INFECT
IONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sep/3/2020 21:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136100
Page 170 of 179
***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, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-07-2020 05:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE URINARY
TRACT
INFECTION:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Is this serious event associ
ated with congenital anoma
ly or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requiInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136101
Page 171 of 179
***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, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
re or prolong hospitalizatio
n?
YES
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
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.
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-10-2020 17:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Sep-10-2020 08:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Query 1: Answered PER
INVESTIGATOR
CORRECT AS
RECORDED. NOT
RELATED TO
OBSTRUCTED
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136102
Page 172 of 179
***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, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
RENAL STENT.
Sep-09-2020 08:29:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Please consider if
the SAE of UTI is
related to the AE of
Obstructed Renal
Stent, which is also
reported in the SAE
narrative
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
URINARY TRACT I
NFECTIONInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-04-2020 10:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-04-2020 10:39:35
(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
Sep-04-2020 10:39:35 ACV0PFEINFP6000 Matthew Data Entry: Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136103
Page 173 of 179
***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, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
(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
Sep-09-2020
07:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed issue resolved
Sep-08-2020
07:54:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-08-2020
07:54:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT RECOVERED
/NOT RESOLVEDTranscription Error
Sep-07-2020
05:10:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2020345173
,outcome was reported as Not
recovered/Not resolved in
SAE form however,recorded
as
RECOVERING/RESOLVING
on AE CRF.Please confirm
correct outcome.If safety
update is required,please
submit a follow-up form
Sep-04-2020
10:39:35
(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?
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136104
Page 174 of 179
***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, Deleted, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Sep-04-2020 10:39:35
(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
Sep-07-2020 05:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020345173Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136105
Page 175 of 179
***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: 10131084 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-17-2021 16:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Dec/22/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136106
Page 176 of 179
***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: 10131084 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
Feb-17-2021 16:11:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-17-2021 16:11:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-17-2021 16:11:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per local/national
recommendations and con
firmed to have received on
ly placebo at Vaccination
1/2Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136107
Page 177 of 179
***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: 10131084 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
Feb-17-2021 16:11:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Dec/22/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-17-2021 16:11:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136108
Page 178 of 179
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-02-2020 08:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-05-2020 13:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-05-2020 12:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-02-2020 08:07:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
Aug-05-2020 13:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/5/2020Initial Entry
Aug-05-2020 12:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/5/2020Initial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136109
Page 179 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131084 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-14-2020 16:24:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe mcooper)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f63\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0136110