Document text
Page 1 of 206
***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: 10151225 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141647
Page 2 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/15/2020
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141648
Page 3 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151225]
2.Birth Date: /1995
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141649
Page 4 of 206
***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: 10151225 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/15/2020
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141650
Page 5 of 206
***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: 10151225 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141651
Page 6 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141652
Page 7 of 206
***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: 10151225 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:[Anxiety]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141653
Page 8 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [95.0]
3.Unit: LB
4.Height: [58.0]
5.Unit: in
6.Body Mass Index: [19.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141654
Page 9 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141655
Page 10 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [89727]
3.Randomization Group: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141656
Page 11 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BP9J3F]
5.bSample ID [BLD0H2]
5.cSample ID [BLD0H0]
5.dSample ID [BLD0H1]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141657
Page 12 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BP9J3D]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141658
Page 13 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 09:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141659
Page 14 of 206
***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: 10151225 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141660
Page 15 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141661
Page 16 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141662
Page 17 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141663
Page 18 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BP9HLL]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141664
Page 19 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/8/2020 09:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141665
Page 20 of 206
***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: 10151225 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/5/2020
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141666
Page 21 of 206
***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: 10151225 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/5/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFKG6]
5.bSample ID [BSH173]
5.cSample ID [BSH174]
5.dSample ID [BSH175]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141667
Page 22 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141668
Page 23 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141669
Page 24 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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 [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141670
Page 25 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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 [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141671
Page 26 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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?
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141672
Page 27 of 206
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141673
Page 28 of 206
***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: 10151225 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:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141674
Page 29 of 206
***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: 10151225 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 [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141675
Page 30 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141676
Page 31 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141677
Page 32 of 206
***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: 10151225 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/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141678
Page 33 of 206
***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: 10151225 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: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141679
Page 34 of 206
***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: 10151225 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:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141680
Page 35 of 206
***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: 10151225 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 [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141681
Page 36 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Dizziness Oct/8/2020 20:0
0 NO
End Date Time:
Oct/12/2020 UNK:U
NK
Repeating
Pages
2.ADVERSE E
VENT 2 Injection site pain Dec/23/2020 UN
K:UNK NO
End Date Time:
Dec/24/2020 UNK:U
NK
Repeating
Pages
3.ADVERSE E
VENT 3 General muscle aches Dec/23/2020 UN
K:UNK NO
End Date Time:
Dec/24/2020 UNK:U
NK
Repeating
Pages
4.ADVERSE E
VENT 4 Swollen neck lymph node
s - both sides Dec/23/2020 UN
K:UNK NO
End Date Time:
Dec/24/2020 UNK:U
NK
Repeating
Pages
5.ADVERSE E
VENT 5 Fever 100.7 Dec/23/2020 UN
K:UNK NO
End Date Time:
Dec/24/2020 UNK:U
NK
Repeating
Pages
6.ADVERSE E
VENT 6 Fatigue Jan/14/2021 13:0
0 NO
End Date Time:
Jan/16/2021 UNK:UN
K
Repeating
Pages
7.ADVERSE E
VENT 7 Headache Jan/14/2021 13:0
0 NO
End Date Time:Repeating
Pages
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141682
Page 37 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
Jan/16/2021 UNK:UN
K
8.ADVERSE E
VENT 8 Myalgia Jan/14/2021 13:0
0 NO
End Date Time:
Jan/16/2021 UNK:UN
K
Repeating
Pages
9.ADVERSE E
VENT 9 Chills Jan/14/2021 13:0
0 NO
End Date Time:
Jan/16/2021 UNK:UN
K
Repeating
Pages
10.ADVERSE E
VENT 10 Fever 101.0 Jan/14/2021 13:0
0 NO
End Date Time:
Jan/16/2021 UNK:UN
K
Repeating
Pages
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141683
Page 38 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10151225 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)[Dizziness]
4.Start Date Time: Oct/8/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/12/2020 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141684
Page 39 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141685
Page 40 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection site pain]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/24/2020 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141686
Page 41 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141687
Page 42 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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)[General muscle aches]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/24/2020 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141688
Page 43 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141689
Page 44 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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)[Swollen neck lymph nodes - both sides]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/24/2020 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141690
Page 45 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141691
Page 46 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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)[Fever 100.7]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/24/2020 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141692
Page 47 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141693
Page 48 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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)[Fatigue]
4.Start Date Time: Jan/14/2021 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/16/2021 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141694
Page 49 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141695
Page 50 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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)[Headache]
4.Start Date Time: Jan/14/2021 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/16/2021 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141696
Page 51 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141697
Page 52 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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)[Myalgia]
4.Start Date Time: Jan/14/2021 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/16/2021 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141698
Page 53 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141699
Page 54 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Jan/14/2021 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/16/2021 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141700
Page 55 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141701
Page 56 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fever 101.0]
4.Start Date Time: Jan/14/2021 13:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/16/2021 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141702
Page 57 of 206
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141703
Page 58 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141704
Page 59 of 206
***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: 10151225 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[ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141705
Page 60 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO Flucelvax Oct/23/2
020 Repeating
Pages
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141706
Page 61 of 206
***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: 10151225 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).[Flucelvax]
5.Date: Oct/23/2020
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141707
Page 62 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141708
Page 63 of 206
***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: 10151225 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?
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141709
Page 64 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141710
Page 65 of 206
***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: 10151225 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?
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141711
Page 66 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141712
Page 67 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141713
Page 68 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141714
Page 69 of 206
***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: 10151225 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:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141715
Page 70 of 206
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141716
Page 71 of 206
***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: 10151225 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?
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141717
Page 72 of 206
***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: 10151225 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: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141718
Page 73 of 206
***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: 10151225 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: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141719
Page 74 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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/17/2020
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141720
Page 75 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141721
Page 76 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141722
Page 77 of 206
***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: 10151225 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/22/2020
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141723
Page 78 of 206
***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: 10151225 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141724
Page 79 of 206
***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: 10151225 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/22/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141725
Page 80 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141726
Page 81 of 206
***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: 10151225 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/22/2020
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 [BRFKNG]
5.bSample ID [BSN5F0]
5.cSample ID [BSN5DD]
5.dSample ID [BSN5DF]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141727
Page 82 of 206
***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: 10151225 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/22/2020
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 [BRFKN4]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141728
Page 83 of 206
***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: 10151225 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/22/2020 11:05
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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141729
Page 84 of 206
***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: 10151225 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/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141730
Page 85 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141731
Page 86 of 206
***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: 10151225 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: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141732
Page 87 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141733
Page 88 of 206
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/14/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141734
Page 89 of 206
***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: 10151225 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/14/2021
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 [BR707S]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141735
Page 90 of 206
***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: 10151225 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/14/2021 09:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141736
Page 91 of 206
***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: 10151225 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/17/2021
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141737
Page 92 of 206
***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: 10151225 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/17/2021
3.Comments: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141738
Page 93 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141739
Page 94 of 206
***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: 10151225 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: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141740
Page 95 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141741
Page 96 of 206
***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: 10151225 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: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141742
Page 97 of 206
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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/17/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141743
Page 98 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/5/2020
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141744
Page 99 of 206
***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: 10151225 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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141745
Page 100 of 206
***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: 10151225 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 12:16:17 (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.
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141746
Page 101 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-15-2020 12:20:28 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141747
Page 102 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-22-2020 13:52:21 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141748
Page 103 of 206
***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: 10151225 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 12:16:17 (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-16-2021 16:45:49 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Jan-22-2021 15:18:15 (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 12:27:51 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141749
Page 104 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Elizabeth
Barnett Approved Jan-21-2021 08:17:01 (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 Dec-22-2020 13:51:40 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Nov-06-2020 19:44:06 (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.
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141750
Page 105 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-15-2020 12:19:56
(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
Sep-15-2020 12:19:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141751
Page 106 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-15-2020 12:20:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/15/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141752
Page 107 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-15-2020 12:19:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10151225Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-15-2020 12:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
/1995Transcription Error
Sep-15-2020 12:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1995Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-15-2020 12:20:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-15-2020 12:20:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-15-2020 12:20:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0141753
Page 108 of 206
***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: 10151225 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-15-2020 12:20:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141754
Page 109 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-15-2020 12:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-15-2020 12:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-15-2020 12:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141755
Page 110 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Sep-15-2020 12:20:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Anxiety
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-15-2020 12:20:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 12:20:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
AnxietyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-15-2020 12:20:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-15-2020 12:20:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141756
Page 111 of 206
***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: 10151225 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-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
95.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
58.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-15-2020 12:21:45
(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
Sep-15-2020 12:21:45
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19.9Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141757
Page 112 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier
::1
Temperature: 99.1
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
99.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-15-2020 12:21:45
(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
Sep-15-2020 12:21:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141758
Page 113 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141759
Page 114 of 206
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Sep-15-2020 12:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141760
Page 115 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-15-2020 12:28:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-15-2020 12:28:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
89727Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141761
Page 116 of 206
***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: 10151225 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-17-2020 13:00:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 13:00:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 13:00:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 13:00:28
(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.
Sep-17-2020 13:00:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 13:00:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9J3FInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141762
Page 117 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 13:00:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9J3FInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020 13:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0H2Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020 13:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0H2Initial Entry
5.c
Date Location User Value Reason
Sep-17-2020 13:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0H0Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020 13:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0H0Initial Entry
5.d
Date Location User Value Reason
Sep-17-2020 13:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0H1Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141763
Page 118 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Sep-17-2020 13:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0H1Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141764
Page 119 of 206
***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: 10151225 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-17-2020 13:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 13:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 13:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 13:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 13:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 13:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9J3DInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141765
Page 120 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 13:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9J3DInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141766
Page 121 of 206
***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: 10151225 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-15-2020 12:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 12:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 12:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-15-2020 12:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020 09:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 12:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-15-2020 12:28:31
(UTC-05:00) EasternACV0PFEINFP6000 Taylor
StannardData Entry:
RIGHTInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141767
Page 122 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.tstannard)
7. Route:
Date Location User Value Reason
Sep-15-2020 12:28:31
(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
Sep-15-2020 12:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-15-2020 12:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141768
Page 123 of 206
***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: 10151225 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
Sep-15-2020 12:29:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141769
Page 124 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 01:57:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Closed Closed as data
updated.
Oct-15-2020 14:34:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered Changed data per
query
Oct-09-2020 08:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe.reddyr51)Query 1: Opened DM: Kindly
review and
complete ‘Nasal
Swab form' at this
visit. Thank you.
Oct-08-2020 13:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/8/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141770
Page 125 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020 13:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/8/2020Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020 13:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier
::1
Temperature: 98.7
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-08-2020 13:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-08-2020 13:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-08-2020 13:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141771
Page 126 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.a Temperature Location:
Date Location User Value Reason
Oct-08-2020 13:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141772
Page 127 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141773
Page 128 of 206
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Oct-08-2020 13:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141774
Page 129 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 14:34:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 14:34:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 14:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 14:34:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 14:34:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 14:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9HLLInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141775
Page 130 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 14:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HLLInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141776
Page 131 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/8/2020 09:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) EasternACV0PFEINFP6000 Taylor
StannardData Entry:
RIGHTInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141777
Page 132 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.tstannard)
7. Route:
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-08-2020 13:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141778
Page 133 of 206
***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: 10151225 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-05-2020 14:45:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Nov/5/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141779
Page 134 of 206
***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: 10151225 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-06-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 14:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-06-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020 14:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKG6Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141780
Page 135 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 14:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKG6Initial Entry
5.b
Date Location User Value Reason
Nov-06-2020 14:42:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH173Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020 14:42:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH173Initial Entry
5.c
Date Location User Value Reason
Nov-06-2020 14:42:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH174Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020 14:42:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH174Initial Entry
5.d
Date Location User Value Reason
Nov-06-2020 14:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH175Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141781
Page 136 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Nov-06-2020 14:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH175Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141782
Page 137 of 206
***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: 10151225 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-05-2020 14:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020 14:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-05-2020 14:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141783
Page 138 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-05-2020 14:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141784
Page 139 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-20-2021 17:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141785
Page 140 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-20-2021 17:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141786
Page 141 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-20-2021 17:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141787
Page 142 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-20-2021 17:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141788
Page 143 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-24-2021 12:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141789
Page 144 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-24-2021 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141790
Page 145 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-24-2021 13:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141791
Page 146 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-24-2021 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141792
Page 147 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-24-2021 13:11:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141793
Page 148 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020 14:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020 14:46:53
(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
Nov-05-2020 14:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
DizzinessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020 14:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/8/2020 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 14:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Oct/12/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141794
Page 149 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-05-2020 14:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial 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
Nov-05-2020 14:46:53
(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
Nov-05-2020 14:46:53
(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
Nov-05-2020 14:46:53
(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
Nov-05-2020 14:46:53
(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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141795
Page 150 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-05-2020 14:46:53
(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
Nov-05-2020 14:46:53
(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
Nov-05-2020 14:46:53
(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
Nov-05-2020 14:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141796
Page 151 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-20-2021 17:25:46
(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-20-2021 17:25:46
(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
Jan-20-2021 17:25:46
(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-20-2021 17:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021 17:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Dec/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141797
Page 152 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-20-2021 17:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial 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
Jan-20-2021 17:25:46
(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-20-2021 17:25:46
(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-20-2021 17:25:46
(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-20-2021 17:25:46
(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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141798
Page 153 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-20-2021 17:25:46
(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-20-2021 17:25:46
(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
Jan-20-2021 17:25:46
(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-20-2021 17:25:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141799
Page 154 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-20-2021 17:26:11
(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-20-2021 17:26:11
(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
Jan-20-2021 17:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
General muscle achesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-20-2021 17:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021 17:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Dec/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141800
Page 155 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-20-2021 17:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial 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
Jan-20-2021 17:26:11
(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-20-2021 17:26:11
(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-20-2021 17:26:11
(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-20-2021 17:26:11
(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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141801
Page 156 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-20-2021 17:26:11
(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
Jan-20-2021 17:26:11
(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
Jan-20-2021 17:26:11
(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-20-2021 17:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141802
Page 157 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-20-2021 17:26:39
(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-20-2021 17:26:39
(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
Jan-21-2021 13:26:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Svitlana
Tonkovyd
(pfe.tonkovs)Query 1: Closed Response satisfies
query
Jan-21-2021 13:17:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-21-2021 13:17:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Swollen neck lymph nodes - bot
h sidesTranscription Error
Jan-21-2021 12:31:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Svitlana
Tonkovyd
(pfe.tonkovs)Query 1: Opened GPD Clin: Please
can you update the
verbatim term to
include swollen
neck lymph nodes
location - right or
left side? Thanks
Jan-20-2021 17:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Swollen neck lymph nodesInitial Entry
4. Start Date Time:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141803
Page 158 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Jan-20-2021 17:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021 17:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Dec/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-20-2021 17:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial 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
Jan-20-2021 17:26:39
(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-20-2021 17:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141804
Page 159 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Jan-20-2021 17:26:39
(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-20-2021 17:26:39
(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-20-2021 17:26:39
(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
Jan-20-2021 17:26:39
(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
Jan-20-2021 17:26:39
(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-20-2021 17:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141805
Page 160 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-20-2021 17:27:20
(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-20-2021 17:27:20
(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-20-2021 17:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Fever 100.7Initial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-20-2021 17:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021 17:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Dec/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141806
Page 161 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-20-2021 17:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial 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
Jan-20-2021 17:27:20
(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-20-2021 17:27:20
(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-20-2021 17:27:20
(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-20-2021 17:27:20
(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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141807
Page 162 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-20-2021 17:27:20
(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
Jan-20-2021 17:27:20
(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
Jan-20-2021 17:27:20
(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-20-2021 17:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141808
Page 163 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-24-2021 12:48:44
(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-24-2021 12:48:44
(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-24-2021 12:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-24-2021 12:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021 12:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/16/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141809
Page 164 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-24-2021 12:48:44
(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
Feb-24-2021 12:48:44
(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-24-2021 12:48:44
(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-24-2021 12:48:44
(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-24-2021 12:48:44
(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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141810
Page 165 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-24-2021 12:48:44
(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-24-2021 12:48:44
(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
Feb-24-2021 12:48:44
(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-24-2021 12:48:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141811
Page 166 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-24-2021 12:49:13
(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-24-2021 12:49:13
(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-24-2021 12:49:13
(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-24-2021 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/16/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141812
Page 167 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-03-2021 13:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Brent Spears
(pfe.spearj09)Query 1: Closed Response satisfies
query
Mar-03-2021 11:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Mar-03-2021 11:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Casey Norton
(pfe.cnorton)Data Entry:
2Changed
Information
Mar-02-2021 09:06:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Marjo
Virtanen
(pfe.virtam)Query 1: Opened Please check
toxicity grade and
reconcile eCRF.
Feb-24-2021 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial 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
Feb-24-2021 12:49:13
(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-24-2021 12:49:13
(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-24-2021 12:49:13 ACV0PFEINFP6000 Taylor Data Entry: Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141813
Page 168 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)Stannard
(pfe.tstannard)RELATED
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-24-2021 12:49:13
(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-24-2021 12:49:13
(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-24-2021 12:49:13
(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
Feb-24-2021 12:49:13
(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-24-2021 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141814
Page 169 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-24-2021 13:10:27
(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-24-2021 13:10:27
(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-24-2021 13:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
MyalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-24-2021 13:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021 13:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/16/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141815
Page 170 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-03-2021 13:21:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Brent Spears
(pfe.spearj09)Query 1: Closed Response satisfies
query
Mar-03-2021 11:30:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Mar-03-2021 11:30:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Casey Norton
(pfe.cnorton)Data Entry:
2Changed
Information
Mar-02-2021 09:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Marjo
Virtanen
(pfe.virtam)Query 1: Opened Please check
toxicity grade and
reconcile eCRF.
Feb-24-2021 13:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial 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
Feb-24-2021 13:10:27
(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-24-2021 13:10:27
(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-24-2021 13:10:27 ACV0PFEINFP6000 Taylor Data Entry: Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141816
Page 171 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)Stannard
(pfe.tstannard)RELATED
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-24-2021 13:10:27
(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-24-2021 13:10:27
(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-24-2021 13:10:27
(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
Feb-24-2021 13:10:27
(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-24-2021 13:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141817
Page 172 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-24-2021 13:10:51
(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-24-2021 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-24-2021 13:10:51
(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-24-2021 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/16/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141818
Page 173 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-24-2021 13:10:51
(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
Feb-24-2021 13:10:51
(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-24-2021 13:10:51
(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-24-2021 13:10:51
(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-24-2021 13:10:51
(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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141819
Page 174 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-24-2021 13:10:51
(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-24-2021 13:10:51
(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
Feb-24-2021 13:10:51
(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-24-2021 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141820
Page 175 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-24-2021 13:11:18
(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-24-2021 13:11:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-24-2021 13:11:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Fever 101.0Initial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-24-2021 13:11:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021 13:11:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Jan/16/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141821
Page 176 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-24-2021 13:11:18
(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
Feb-24-2021 13:11:18
(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-24-2021 13:11:18
(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-24-2021 13:11:18
(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-24-2021 13:11:18
(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
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141822
Page 177 of 206
***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, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-24-2021 13:11:18
(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-24-2021 13:11:18
(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
Feb-24-2021 13:11:18
(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-24-2021 13:11:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141823
Page 178 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-05-2020 14:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141824
Page 179 of 206
***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: 10151225 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-05-2020 14:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-05-2020 14:50:05
(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-05-2020 14:50:05
(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-05-2020 14:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FlucelvaxInitial Entry
5. Date:
Date Location User Value Reason
Nov-05-2020 14:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/23/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141825
Page 180 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-22-2020 13:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/17/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141826
Page 181 of 206
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 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-22-2020 13:51:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141827
Page 182 of 206
***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: 10151225 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-22-2020 13:52:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/22/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141828
Page 183 of 206
***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: 10151225 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-22-2020 13:52:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/22/2020Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141829
Page 184 of 206
***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: 10151225 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-22-2020 13:52:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-22-2020 13:52:32
(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-22-2020 13:52:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141830
Page 185 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141831
Page 186 of 206
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Dec-22-2020 13:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141832
Page 187 of 206
***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: 10151225 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-04-2021 15:06:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 15:06:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-04-2021 15:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-04-2021 15:06:14
(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-04-2021 15:06:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Dec/22/2020Initial Entry
5.a
Date Location User Value Reason
Jan-04-2021 15:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKNGInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141833
Page 188 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Jan-04-2021 15:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKNGInitial Entry
5.b
Date Location User Value Reason
Jan-04-2021 15:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5F0Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-04-2021 15:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5F0Initial Entry
5.c
Date Location User Value Reason
Jan-05-2021 09:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5DDInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-05-2021 09:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5DDInitial Entry
5.d
Date Location User Value Reason
Jan-05-2021 09:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5DFInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141834
Page 189 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Jan-05-2021 09:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5DFInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141835
Page 190 of 206
***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: 10151225 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-04-2021 14:49:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 14:49:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-04-2021 14:51:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-04-2021 14:49:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-04-2021 14:49:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Dec/22/2020Initial Entry
5.a
Date Location User Value Reason
Jan-04-2021 14:51:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKN4Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141836
Page 191 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Jan-04-2021 14:51:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKN4Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141837
Page 192 of 206
***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: 10151225 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-22-2020 13:53:12
(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-22-2020 13:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-22-2020 13:53:12
(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-22-2020 13:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/22/2020 11:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-22-2020 13:53:12
(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-22-2020 13:53:12
(UTC-05:00) EasternACV0PFEINFP6000 Taylor
StannardData Entry:
LEFTInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141838
Page 193 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.tstannard)
7. Route:
Date Location User Value Reason
Dec-22-2020 13:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-22-2020 13:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-22-2020 13:53:12
(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-22-2020 13:53:12
(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-22-2020 13:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141839
Page 194 of 206
***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: 10151225 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-22-2020 13:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-22-2020 13:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141840
Page 195 of 206
***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: 10151225 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-22-2021 01:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Jan-21-2021 12:28:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered Changed data per
query
Jan-21-2021 08:45:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe.reddyr51)Query 1: Opened DM: Kindly
review and
complete ‘Nasal
Swab' form at this
visit. Thank you.
Jan-20-2021 17:23:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021Initial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141841
Page 196 of 206
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/14/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141842
Page 197 of 206
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Jan-20-2021 17:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141843
Page 198 of 206
***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: 10151225 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 12:27:51
(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 12:27:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-21-2021 12:27:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-21-2021 12:27:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-21-2021 12:27:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Feb-16-2021 16:45:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BR707STranscription Error
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141844
Page 199 of 206
***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: 10151225 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Jan-21-2021 12:27:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: MR707SInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-16-2021 16:45:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BR707STranscription Error
Jan-21-2021 12:27:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
MR707SInitial Entry
090177e196ae3fe7\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141845
Page 200 of 206
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10151225 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
Jan-20-2021 17:24:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-20-2021 17:24:22
(UTC-05:00) Eastern
Time (US & Canad
…[truncated]