Document text
Page 1 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141440
Page 2 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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/27/2020
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141441
Page 3 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151134]
2.Birth Date: /1965
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141442
Page 4 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141443
Page 5 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141444
Page 6 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141445
Page 7 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Childhood asthma]
Start Date: UNK/UNK/1975
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Acid reflux]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Vertigo]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141446
Page 8 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [165.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [22.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141447
Page 9 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [70275]
3.Randomization Group: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141448
Page 10 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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/27/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLD08S]
5.bSample ID [BLD08T]
5.cSample ID [BM8F23]
5.dSample ID [BM8F24]
5.eSample ID [BM8F25]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141449
Page 11 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8F1W]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141450
Page 12 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 14:39
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
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141451
Page 13 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141452
Page 14 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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/17/2020
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141453
Page 15 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141454
Page 16 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141455
Page 17 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141456
Page 18 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141457
Page 19 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSH17L]
5.bSample ID [BSH17D]
5.cSample ID [BSH17F]
5.dSample ID [BRFKGB]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141458
Page 20 of 207
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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:
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141459
Page 21 of 207
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141460
Page 22 of 207
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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 [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141461
Page 23 of 207
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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 [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141462
Page 24 of 207
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141463
Page 25 of 207
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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:
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141464
Page 26 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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:
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141465
Page 27 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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 [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141466
Page 28 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141467
Page 29 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141468
Page 30 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141469
Page 31 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141470
Page 32 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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:
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141471
Page 33 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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 [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141472
Page 34 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Worsening and continuing episod
e of Veritgo Aug/28/2020 UNK
:UNK NO
End Date Time:
Dec/21/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Headache Aug/28/2020 UNK
:UNK NO
End Date Time:
Sep/1/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Nausea Aug/28/2020 UNK
:UNK NO
End Date Time:
Sep/1/2020 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 Diarrhea Aug/28/2020 UNK
:UNK NO
End Date Time:
Aug/28/2020 UNK:UN
K
Repeating
Pages
5.ADVERSE EV
ENT 5 Injection site pain Dec/21/2020 UNK
:UNK NO
End Date Time:
Dec/22/2020 UNK:UNK
Repeating
Pages
6.ADVERSE EV
ENT 6 Chills Jan/13/2021 20:00 NO
End Date Time:
Jan/15/2021 UNK:UNK
Repeating
Pages
7.ADVERSE EV
ENT 7 Injection site pain Jan/13/2021 20:00 NO
End Date Time:
Jan/15/2021 UNK:UNK
Repeating
Pages
8.ADVERSE EV
ENT 8 Headache Jan/14/2021 03:00 NO
End Date Time:
Jan/15/2021 UNK:UNK
Repeating
Pages
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141473
Page 35 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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)[Worsening and continuing episode of Veritgo]
4.Start Date Time: Aug/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/21/2020 UNK:UNK
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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141474
Page 36 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141475
Page 37 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Aug/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/1/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141476
Page 38 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141477
Page 39 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Nausea]
4.Start Date Time: Aug/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/1/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141478
Page 40 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141479
Page 41 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diarrhea]
4.Start Date Time: Aug/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141480
Page 42 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141481
Page 43 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection site pain]
4.Start Date Time: Dec/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/22/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141482
Page 44 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141483
Page 45 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Jan/13/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/15/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141484
Page 46 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141485
Page 47 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection site pain]
4.Start Date Time: Jan/13/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/15/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141486
Page 48 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141487
Page 49 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Jan/14/2021 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/15/2021 UNK:UNK
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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141488
Page 50 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141489
Page 51 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
1. Repeating Pages
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141490
Page 52 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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[ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141491
Page 53 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Dat
eForm Instance
1.1 VACCINATIONS NO Fluzone Quadriva
lent Sep/28/20
20 Repeating
Pages
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141492
Page 54 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Fluzone Quadrivalent]
5.Date: Sep/28/2020
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141493
Page 55 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141494
Page 56 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141495
Page 57 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141496
Page 58 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141497
Page 59 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141498
Page 60 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141499
Page 61 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141500
Page 62 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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:
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141501
Page 63 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141502
Page 64 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141503
Page 65 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141504
Page 66 of 207
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141505
Page 67 of 207
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141506
Page 68 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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/21/2020
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141507
Page 69 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/21/2020
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141508
Page 70 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141509
Page 71 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Dec/21/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141510
Page 72 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
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 [BSN5CN]
5.bSample ID [BSN5CW]
5.cSample ID [BSN5CX]
5.dSample ID [BRFKMW]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141511
Page 73 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
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 [BRFKMR]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141512
Page 74 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/21/2020 13:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141513
Page 75 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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/14/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141514
Page 76 of 207
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141515
Page 77 of 207
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141516
Page 78 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141517
Page 79 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [BR707N]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141518
Page 80 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 12:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141519
Page 81 of 207
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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/10/2021
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141520
Page 82 of 207
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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:
Feb/10/2021
3.Comments: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141521
Page 83 of 207
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141522
Page 84 of 207
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141523
Page 85 of 207
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141524
Page 86 of 207
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141525
Page 87 of 207
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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 :Feb/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141526
Page 88 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/6/2020
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141527
Page 89 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141528
Page 90 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Elizabeth Barnett Approved Mar-11-2021 10:57:31 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141529
Page 91 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-27-2020 16:37:46 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141530
Page 92 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-22-2020 12:46:24 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141531
Page 93 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Sep-22-2020 12:46:24 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141532
Page 94 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aSep-22-2020 12:46:24 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141533
Page 95 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aSep-22-2020 12:46:24 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141534
Page 96 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aSep-22-2020 12:46:24 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141535
Page 97 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-22-2020 12:46:35 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141536
Page 98 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Sep-22-2020 12:46:35 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141537
Page 99 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Sep-22-2020 12:46:35 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141538
Page 100 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Sep-22-2020 12:46:35 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141539
Page 101 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Sep-22-2020 12:46:35 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141540
Page 102 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141541
Page 103 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141542
Page 104 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141543
Page 105 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141544
Page 106 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141545
Page 107 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141546
Page 108 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141547
Page 109 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141548
Page 110 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141549
Page 111 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141550
Page 112 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
10Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141551
Page 113 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
11Sep-22-2020 12:47:41 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Due to history of vertigo and ongoing episode of
vertigo since last vaccination, study doctor decided to
wait until episode resolves.
Not Done
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141552
Page 114 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-21-2020 13:42:52 (UTC-05:00) Eastern Time
(US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141553
Page 115 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Elizabeth Barnett Approved Mar-11-2021 10:57:31 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
Taylor Stannard N/A Feb-12-2021 13:04:21 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth Barnett Approved Jan-22-2021 15:11:36 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
Taylor Stannard N/A Jan-21-2021 12:26:03 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth Barnett Approved Jan-20-2021 19:53:50 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141554
Page 116 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
Taylor Stannard N/A Dec-21-2020 13:41:58 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth Barnett Approved Nov-13-2020 16:18:20 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
Taylor Stannard N/A Nov-11-2020 15:30:25 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth Barnett Approved Nov-09-2020 10:38:07 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
Taylor Stannard N/A Nov-07-2020 14:08:36 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141555
Page 117 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
N/A
Elizabeth Barnett Approved Nov-06-2020 19:33:28 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141556
Page 118 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-27-2020 16:34:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 16:34:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141557
Page 119 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-27-2020 16:34:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141558
Page 120 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-27-2020 16:34:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10151134Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 16:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 16:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 16:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 16:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141559
Page 121 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 16:37:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/27/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141560
Page 122 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-27-2020 16:37:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 16:37:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 16:37:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141561
Page 123 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 16:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Childhood asth
ma
Start Date: UNK/UNK/197
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 16:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 16:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Childhood asthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 16:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/1975Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 16:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-27-2020 16:39:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141562
Page 124 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical History Ter
m:Acid reflux
Start Date: UNK/UNK/200
0
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020 16:39:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 16:39:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Acid refluxInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 16:39:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 16:39:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-22-2020 12:27:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Vertigo
Start Date: UNK/UNK/20
12
Ongoing: YESTranscription Error
Sep-22-2020 12:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141563
Page 125 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical History Ter
m:Vertigo
Start Date: UNK/UNK/20
18
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-22-2020 12:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020 12:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
VertigoInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-22-2020 12:27:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2012Transcription Error
Sep-22-2020 12:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-22-2020 12:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141564
Page 126 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
165.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.4Initial Entry
7.a
Date Location User Value Reason
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141565
Page 127 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 16:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141566
Page 128 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-27-2020 16:40:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 16:40:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
70275Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141567
Page 129 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 21:31:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 21:31:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 21:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 21:31:41
(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-27-2020 21:31:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 21:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD08SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 21:31:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD08SInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141568
Page 130 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b
Date Location User Value Reason
Aug-27-2020 21:32:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD08TInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 21:32:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD08TInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 21:32:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8F23Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 21:32:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F23Initial Entry
5.d
Date Location User Value Reason
Aug-27-2020 21:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8F24Transcription Error
Aug-27-2020 21:32:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8F244Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141569
Page 131 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 21:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 21:32:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F24Transcription Error
Aug-27-2020 21:32:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as appropriate.
Aug-27-2020 21:32:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F244Initial Entry
5.e
Date Location User Value Reason
Aug-27-2020 21:32:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8F25Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 21:32:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F25Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141570
Page 132 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 21:33:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 21:33:12
(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 21:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 21:33:12
(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-27-2020 21:33:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 21:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8F1WInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 21:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F1WInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141571
Page 133 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 16:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 16:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 16:40:50
(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-27-2020 16:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/27/2020 14:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 16:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 16:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141572
Page 134 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-27-2020 16:40:50
(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-27-2020 16:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-27-2020 16:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141573
Page 135 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-27-2020 16:41:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141574
Page 136 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-22-2020 12:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/17/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141575
Page 137 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 12:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Sep-22-2020 12:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier:: Not Done
Temperature: Not Done
Temperature Unit: Not Done
Temperature Location:: Not DoneInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 12:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 12:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020 12:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020 12:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141576
Page 138 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-22-2020 12:46:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 12:46:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 12:46:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-22-2020 12:46:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141577
Page 139 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141578
Page 140 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-22-2020 12:47:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not DoneInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141579
Page 141 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020 15:21:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laurie Hawes
(pfe hawesl01)Query 1: Closed Response satisfies
query
Nov-07-2020 14:10:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered PI made decision to
not have subject
receive second dose
due to worsening
vertigo. Subject did not
attend second visit, and
after rep-contacting
they chose to come
back for their visit 3
Nov-07-2020 03:31:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Swapna
Varikuti
(pfe.variks)Query 1: Opened PDQ: DOV at this visit
is out of window (15
day) from DOV
(17/Sep/2020) at V2.
Please either update
DOV or confirm
whether visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Nov-06-2020 15:23:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Nov/6/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141580
Page 142 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-07-2020 14:08:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-07-2020 14:08:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-07-2020 14:08:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-07-2020 14:08:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH17LInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-07-2020 14:08:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH17LInitial Entry
5.b
Date Location User Value Reason
Nov-07-2020 14:11:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH17DInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141581
Page 143 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Sample ID
Date Location User Value Reason
Nov-07-2020 14:11:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH17DInitial Entry
5.c
Date Location User Value Reason
Nov-07-2020 14:11:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH17FInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-07-2020 14:11:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH17FInitial Entry
5.d
Date Location User Value Reason
Nov-07-2020 14:15:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKGBInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-07-2020 14:15:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKGBInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141582
Page 144 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Nov-06-2020 15:23:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Nov/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-06-2020 15:23:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020 10:27:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 2: Closed Response satisfies
query
Nov-12-2020 10:05:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-12-2020 10:04:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Response to "Status" is
ADVERSE EVENT
but "Specify Status" is
Provided.
Nov-12-2020 10:04:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Nov-12-2020 10:04:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ADVERSE EVENTNew Information
Nov-12-2020 02:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 3: Reissued:Opened DM: "Specify Status"
(item4) is not required
if Status is
"PHYSICIAN
DECISION" at (item
3). Please review and
update accordingly.
Nov-11-2020 15:54:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 2: Reissued:Opened CLINQUERY: If the
event of Worsening
Vertigo was involved
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141583
Page 145 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
in the decision to cease
treatment, please
consider updating this
EOT status to be
ADVERSE EVENT to
link
Nov-11-2020 15:30:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 3: Answered Changed data per
query
Nov-11-2020 15:30:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 2: Answered Changed data per
query
Nov-11-2020 15:30:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Response to "Status" is
PHYSICIAN
DECISION but
"Specify Status" is
Provided.
Nov-11-2020 09:14:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 2: Opened CLINQUERY: Please
clarify the conditions
leading to the decision
to discontinue
treatment. If any of the
adverse events
contributed to this
decision, they should
be indicated and status
field updated
Nov-07-2020 15:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laurie Hawes
(pfe hawesl01)Query 1: Closed Response satisfies
query
Nov-07-2020 14:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-07-2020 14:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
PHYSICIAN DECISIONNew Information
Nov-07-2020 09:12:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R
(pfe rb01)Query 1: Opened Subject has not
received vaccination 2,
hence status cannot be
COMPLETED. Please
verify and update as
appropriate. Else
clarify.
Nov-06-2020 15:23:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141584
Page 146 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4. Specify Status:
Date Location User Value Reason
Nov-12-2020 10:05:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry: New Information
Nov-11-2020 15:30:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Due to worsening vertigo post vaccine
one, PI decided that second dose shoul
d be skipped for safety.Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141585
Page 147 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141586
Page 148 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141587
Page 149 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141588
Page 150 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141589
Page 151 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141590
Page 152 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141591
Page 153 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141592
Page 154 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141593
Page 155 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-11-2020 18:42:05
(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-11-2020 18:42:05
(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
Sep-24-2020
05:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Pratiksha Mahadik
(pfe mahadp07)Query 4: Closed Closed as data
updated.
Sep-23-2020
10:02:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answe
redNew Information
Sep-23-2020
10:02:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Data Entry:
Worsening and c
ontinuing episod
e of VeritgoNew Information
Sep-23-2020
04:07:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 4: Opene
dThe AE Episode
of Veritgo was
reported but is
also listed in
Medical History.
Please clarify if
this is a worsening
of the baseline
condition, and if
so, please consider
adding
"worsening" to the
AE term. AE as
baseline
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141594
Page 156 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
conditions should
only be reported
as AEs if they
worsen. "[naikp09
SDQ=11049]"
Sep-22-2020
15:41:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Sep-22-2020
15:36:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Closed Event is no longer
a SAE
Sep-22-2020
12:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answe
redNew Information
Sep-22-2020
12:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answe
redNew Information
Sep-22-2020
12:27:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Data Entry:
Episode of Verit
goNew Information
Sep-22-2020
11:51:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Reissu
ed:OpenedCLINQUERY
SAE notes history
of Vertigo 2x;
please consider an
update to Medical
History now that
this is known
Sep-22-2020
11:49:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Opene
dCLINQUERY
please update SAE
with start/stop
dates for Med Hx
of Vertigo, and
update narrative
with years since
most recent
episode (currently
reads "last episode
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141595
Page 157 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
of vertigo years
ago")
Sep-18-2020
15:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Query 2: Answe
redPlease unfreeze
medical history so
I can add, thank
you!
Sep-18-2020
09:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opene
dCLINQUERY
SAE notes history
of VERTIGO 2x
over 10 years ago;
please consider an
update to Medical
History
Sep-14-2020
10:49:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle
(pfe.PFETMS)Query 1: Closed Discrepancy has
been closed.
Sep-12-2020
15:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle
(pfe.PFETMS)Query 1: Opene
dClarify VERITGO
as
follows...Should
spelling be
VERTIGO? If
so,edit. Otherwise,
clarify. Thank
you.
Sep-11-2020
18:42:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Data Entry:
VeritgoInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/28/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021 12:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Katherine
Liau
(pfe.liaukf)Query 1: Closed Response satisfies
query
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141596
Page 158 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-03-2021 10:37:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Mar-03-2021 10:37:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Casey Norton
(pfe.cnorton)Data Entry:
NO
End Date Time:
Dec/21/2020 UNK:UNKNew Information
Mar-02-2021 04:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Katherine
Liau
(pfe.liaukf)Query 1: Opened GPD CLIN: Please
confirm if the subject's
AE is still ongoing
else provide end date
as applicable.
Sep-18-2020 15:16:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESNew Information
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Sep/1/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
2Initial 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-22-2020 15:43:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Sep-22-2020 12:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE Episode of Veritgo:
Response to "Is the adverse
event serious?" is 'No' but
"Serious Adverse Event
Number" is present.
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141597
Page 159 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-18-2020 14:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed site determined adverse
event of vertigo was NOT
serious
Sep-18-2020 09:52:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened ClinQuery For AE Veritgo
[Vertigo]: Response to "Is
the adverse event serious?"
is 'No' but "Serious
Adverse Event Number" is
present and SAE form
checked the 'Disability' box
Sep-18-2020 09:50:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed placed on incorrect SAE
(incorrect SAE #)
Sep-18-2020 06:40:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2020326724
APPENDICITIS(onset
date:17Aug2020)was
reported as serious in
Safety database but not
serious in AE CRF. If this
event is serious,update to
yes.To downgrade the
event in the Safety
Database,please submit
SAE form.
Sep-18-2020 06:37:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Veritgo: Response
to "Is the adverse event
serious?" is 'No' but
"Serious Adverse Event
Number" is present.
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-11-2020 18:42:05
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Taylor
StannardData Entry:
RELATEDInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141598
Page 160 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US & Canada) (pfe.tstannard)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 10:26:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 1: Closed Response satisfies
query
Nov-12-2020 10:05:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-12-2020 10:05:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
DRUG WITHDRAWNNew Information
Nov-11-2020 15:52:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 1: Opened CLINQUERY: Per
EOT comment, it
appears this event of
Worsening Vertigo,
contributed to the
decision to cease
treatment. If so, please
consider updating this
status to DRUG
WITHDRAWN, and
match to an EOT status
of ADVERSE EVENT
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141599
Page 161 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-03-2021 10:37:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-03-2021 10:37:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Casey Norton
(pfe.cnorton)Data Entry:
RECOVERED/RESOLVEDNew Information
Mar-03-2021 10:37:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Worsening and
continuing episode of
Veritgo: Response to
"What was the outcome
of this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-18-2020 15:17:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 15:17:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERING/RESOLVINGNew Information
Sep-18-2020 15:16:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Veritgo:
Response to "What was
the outcome of this
adverse event?" is 3 but
End Date/Time is
missing.
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141600
Page 162 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-11-2020 18:42:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-22-2020 15:43:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Gladys Noi
(pfe noig)Data Entry: AE downgraded from
SAE
Sep-18-2020 06:37:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020361615Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141601
Page 163 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-11-2020 18:57:55
(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-11-2020 18:57:55
(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-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/28/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Sep/1/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141602
Page 164 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141603
Page 165 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-11-2020 18:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141604
Page 166 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-11-2020 18:58:29
(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-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NauseaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/28/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Sep/1/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141605
Page 167 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141606
Page 168 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-11-2020 18:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141607
Page 169 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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-11-2020 18:58:59
(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-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
DiarrheaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/28/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Aug/28/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141608
Page 170 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141609
Page 171 of 207
***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, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-11-2020 18:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141610
Page 172 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Dec/22/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141611
Page 173 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141612
Page 174 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-13-2021 13:54:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141613
Page 175 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/13/2021 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/15/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141614
Page 176 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141615
Page 177 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-12-2021 13:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141616
Page 178 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/13/2021 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/15/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141617
Page 179 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141618
Page 180 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-12-2021 13:09:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141619
Page 181 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/15/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
2Initial Entry
7. Is the adverse event serious?
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141620
Page 182 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)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
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141621
Page 183 of 207
***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, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-12-2021 13:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141622
Page 184 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-06-2020 15:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141623
Page 185 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-06-2020 15:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-06-2020 15:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-06-2020 15:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Nov-06-2020 15:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Fluzone QuadrivalentInitial Entry
5. Date:
Date Location User Value Reason
Nov-06-2020 15:23:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/28/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141624
Page 186 of 207
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021 11:58:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Brent Spears
(pfe.spearj09)Query 1: Closed Response satisfies
query
Jan-06-2021 13:32:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-06-2021 13:32:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/14/2020Transcription Error
Jan-05-2021 17:43:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Brent Spears
(pfe.spearj09)Query 1: Opened Per source, initial
contact completed
14Dec2020. Please
reconcile.
Dec-21-2020 13:42:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141625
Page 187 of 207
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Dec-24-2020 08:45:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 1: Closed site confirms non-study
access under EUA
Dec-23-2020 12:58:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered Subject is eligible to
receive vaccine.
Discontinued treatment
due to new/worsening
vertigo which PI
believed to be related
to invesitgational
product.
Dec-23-2020 11:20:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 1: Opened CLINQUERY: Subject
discontinued treatment
prior to vax 2 due to an
AE. Please review and
clarify the eligibility
and/or the decision to
continue for further
vaccinations.
Dec-21-2020 13:42:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per local/national recomme
ndations and confirmed to have rec
eived only placebo at Vaccination 1
/2Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141626
Page 188 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020 13:42:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141627
Page 189 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Dec-21-2020 13:42:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/21/2020Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141628
Page 190 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Dec-21-2020 13:43:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-21-2020 13:43:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-21-2020 13:43:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141629
Page 191 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-22-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 10:25:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-22-2020 10:25:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-22-2020 10:25:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5CNInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-22-2020 10:25:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5CNInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141630
Page 192 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b
Date Location User Value Reason
Dec-22-2020 10:54:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5CWInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-22-2020 10:54:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5CWInitial Entry
5.c
Date Location User Value Reason
Dec-22-2020 10:55:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5CXInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-22-2020 10:55:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5CXInitial Entry
5.d
Date Location User Value Reason
Dec-22-2020 11:25:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKMWInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-22-2020 11:25:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKMWInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141631
Page 193 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-22-2020 11:54:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 11:54:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 11:54:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 11:54:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-22-2020 11:54:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-22-2020 11:54:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKMRInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-22-2020 11:54:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKMRInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141632
Page 194 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020 13:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141633
Page 195 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-21-2020 13:43:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141634
Page 196 of 207
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Dec-21-2020 13:41:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/14/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-21-2020 13:41:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141635
Page 197 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 13:53:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/13/2021Initial Entry
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141636
Page 198 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 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
Jan-21-2021 12:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 12:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-21-2021 12:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-21-2021 12:26:03
(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.
Jan-21-2021 12:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Feb-16-2021 16:46:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BR707NTranscription Error
Jan-21-2021 12:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: MR707NInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3feb\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141637
Page 199 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151134 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-16-2021 16:46:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BR707NTranscription Error
Jan-21-2021 12:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
MR707NInitial Entry
090177e196ae3feb\
…[truncated]