Document text
Page 1 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141007
Page 2 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/20/2020
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141008
Page 3 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151071]
2.Birth Date: 1988
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141009
Page 4 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141010
Page 5 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141011
Page 6 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141012
Page 7 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141013
Page 8 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [117.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [18.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141014
Page 9 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/20/2020
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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141015
Page 10 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [57976]
3.Randomization Group: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141016
Page 11 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BLD04T]
5.bSample ID [BLD04V]
5.cSample ID [BM8FHJ]
5.dSample ID [BM8FHK]
5.eSample ID [BM8FHL]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141017
Page 12 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BM8FH8]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141018
Page 13 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/20/2020 11:48
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?NO
If No, specify reason:
[Had to leave early for work. Did not report any AE's]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141019
Page 14 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141020
Page 15 of 155
***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: 10151071 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/10/2020
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141021
Page 16 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141022
Page 17 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 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/10/2020
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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141023
Page 18 of 155
***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: 10151071 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/10/2020
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 [BP9J0Z]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141024
Page 19 of 155
***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: 10151071 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/10/2020 10:32
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?NO
If No, specify reason:
[Patient had to leave urgently. Asked to contact us with any concerns.
Expressed understanding.]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141025
Page 20 of 155
***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: 10151071 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/9/2020
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141026
Page 21 of 155
***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: 10151071 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:
Oct/9/2020
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 [BP9HML]
5.bSample ID [BRTRYF]
5.cSample ID [BRTRYG]
5.dSample ID [BRTRYH]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141027
Page 22 of 155
***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: 10151071 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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141028
Page 23 of 155
***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: 10151071 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: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141029
Page 24 of 155
***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: 10151071 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 [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141030
Page 25 of 155
***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: 10151071 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 [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141031
Page 26 of 155
***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: 10151071 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?
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141032
Page 27 of 155
***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: 10151071 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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141033
Page 28 of 155
***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: 10151071 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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141034
Page 29 of 155
***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: 10151071 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 [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141035
Page 30 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141036
Page 31 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141037
Page 32 of 155
***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: 10151071 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 :Oct/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141038
Page 33 of 155
***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: 10151071 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: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141039
Page 34 of 155
***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: 10151071 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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141040
Page 35 of 155
***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: 10151071 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 [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141041
Page 36 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Exposure during preg
nancy Jan/7/2021 UNK:
UNK YES Repeating
Pages
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141042
Page 37 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 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)[Exposure during pregnancy]
4.Start Date Time: Jan/7/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unrelated]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141043
Page 38 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 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?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141044
Page 39 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141045
Page 40 of 155
***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: 10151071 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[ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141046
Page 41 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141047
Page 42 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141048
Page 43 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141049
Page 44 of 155
***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: 10151071 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?
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141050
Page 45 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141051
Page 46 of 155
***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: 10151071 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?
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141052
Page 47 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141053
Page 48 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141054
Page 49 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141055
Page 50 of 155
***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: 10151071 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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141056
Page 51 of 155
***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: 10151071 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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141057
Page 52 of 155
***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: 10151071 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?
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141058
Page 53 of 155
***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: 10151071 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: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141059
Page 54 of 155
***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: 10151071 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: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141060
Page 55 of 155
***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: 10151071 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/15/2020
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141061
Page 56 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141062
Page 57 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141063
Page 58 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/21/2020
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141064
Page 59 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141065
Page 60 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Dec/21/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141066
Page 61 of 155
***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: 10151071 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/21/2020
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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141067
Page 62 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSN5CS]
5.bSample ID [BSN5D2]
5.cSample ID [BSN5D3]
5.dSample ID [BRFKMZ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141068
Page 63 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFKMP]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141069
Page 64 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/21/2020 13:06
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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141070
Page 65 of 155
***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: 10151071 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/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141071
Page 66 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141072
Page 67 of 155
***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: 10151071 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: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141073
Page 68 of 155
***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: 10151071 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/11/2021
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141074
Page 69 of 155
***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: 10151071 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/11/2021
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:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141075
Page 70 of 155
***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: 10151071 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/11/2021
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 [BRFKRY]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141076
Page 71 of 155
***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: 10151071 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/11/2021 11:01
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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141077
Page 72 of 155
***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: 10151071 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/16/2021
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141078
Page 73 of 155
***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: 10151071 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/16/2021
3.Comments: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141079
Page 74 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141080
Page 75 of 155
***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: 10151071 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: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141081
Page 76 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141082
Page 77 of 155
***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: 10151071 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: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141083
Page 78 of 155
***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: 10151071 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/16/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141084
Page 79 of 155
***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: 10151071 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 Oct/9/2020
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141085
Page 80 of 155
***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: 10151071 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
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141086
Page 81 of 155
***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: 10151071 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
BarnettApproved Mar-11-2021 10:32:42 (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.
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141087
Page 82 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-20-2020 11:39:23 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141088
Page 83 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-20-2020 11:41:52 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141089
Page 84 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Feb-24-2021 10:58:07 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141090
Page 85 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-21-2020 13:50:45 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141091
Page 86 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Elizabeth
Barnett Approved Mar-11-2021 10:32:42 (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-24-2021 10:03:02 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Jan-21-2021 19:15:57 (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-21-2020 13:50:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141092
Page 87 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Elizabeth
Barnett Approved Oct-20-2020 20:04:18 (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.
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141093
Page 88 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-20-2020 11:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-20-2020 11:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141094
Page 89 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 11:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/20/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141095
Page 90 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020 11:38:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10151071Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 11:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1988Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 11:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 11:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 11:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141096
Page 91 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 11:39:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141097
Page 92 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-20-2020 11:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 11:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 11:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141098
Page 93 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
117.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18.3Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141099
Page 94 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier:
:1
Temperature: 97.9
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 11:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141100
Page 95 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141101
Page 96 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020 11:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141102
Page 97 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020 11:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 11:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
57976Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141103
Page 98 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 09:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 09:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 09:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 09:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-21-2020 09:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 09:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD04TInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141104
Page 99 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 09:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD04TInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 09:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD04VInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 09:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD04VInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 09:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FHJInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 09:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FHJInitial Entry
5.d
Date Location User Value Reason
Aug-21-2020 09:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FHKInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141105
Page 100 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 09:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FHKInitial Entry
5.e
Date Location User Value Reason
Aug-21-2020 09:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FHLInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-21-2020 09:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FHLInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141106
Page 101 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 09:58:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 09:58:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 09:58:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 09:58:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FH8Transcription Error
Aug-21-2020 09:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FH7Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 09:58:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FH8Transcription Error
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141107
Page 102 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-21-2020 09:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FH7Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141108
Page 103 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/20/2020 11:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141109
Page 104 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Route:
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-24-2020 00:32:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Closed closed per SITE
response, added to
PD review tracker
Aug-21-2020 09:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered Original value is
correct
Aug-21-2020 09:11:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Opened PDQ: Response to
question for
observation post
dose is 'NO'. Please
review and correct
or confirm.
Aug-20-2020 11:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
If No, specify reason:
Had to leave early for work.
Did not report any AE'sInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141110
Page 105 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-20-2020 11:43:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141111
Page 106 of 155
***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: 10151071 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-10-2020 12:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141112
Page 107 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 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-10-2020 12:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020 12:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier:
:1
Temperature: 98.4
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 12:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-10-2020 12:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020 12:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141113
Page 108 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 12:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141114
Page 109 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 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-10-2020 12:18:24
(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-10-2020 12:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020 12:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-10-2020 12:18:24
(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-10-2020 12:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020 12:18:24
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141115
Page 110 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020 12:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020 12:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020 12:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141116
Page 111 of 155
***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: 10151071 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-11-2020 13:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 13:09:30
(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-11-2020 13:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 13:09:30
(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-11-2020 13:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 13:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9J0ZInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141117
Page 112 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 13:09:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9J0ZInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141118
Page 113 of 155
***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: 10151071 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-10-2020 12:18:40
(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-10-2020 12:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 12:18:40
(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-10-2020 12:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/10/2020 10:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 12:18:40
(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-10-2020 12:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141119
Page 114 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Route:
Date Location User Value Reason
Sep-10-2020 12:18:40
(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-10-2020 12:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-10-2020 12:25:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
If No, specify reason:
Patient had to leave urgently.
Asked to contact us with any
concerns. Expressed understa
nding.New Information
Sep-10-2020 12:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141120
Page 115 of 155
***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: 10151071 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-09-2020 15:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/9/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141121
Page 116 of 155
***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: 10151071 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-14-2020 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 12:30:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 12:30:18
(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-14-2020 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020 12:30:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9HMLInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141122
Page 117 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 12:30:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HMLInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020 12:36:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRTRYFInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020 12:36:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRYFInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020 12:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRTRYGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020 12:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRYGInitial Entry
5.d
Date Location User Value Reason
Oct-14-2020 12:44:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRTRYHInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141123
Page 118 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Oct-14-2020 12:44:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRYHInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141124
Page 119 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020 15:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 15:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 15:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141125
Page 120 of 155
***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: 10151071 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 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141126
Page 121 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 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 10:03:02
(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 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021 09:31:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Clinical PG Safety
event start date is
1st day of LMP
(07Jan21). Please
clarify date of
positive urine PG
test, would be a
later date
Feb-24-2021 10:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered Positive pregnancy
test was on
7Jan2021 (start
date)
Feb-24-2021 10:51:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Please
submit a PG safety
report update with
the date of the
positive urine
pregnancy test
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Exposure during pregnancyInitial Entry
4. Start Date Time:
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141127
Page 122 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/7/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-25-2021 09:29:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-24-2021 10:58:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not ApplicableInitial Entry
Feb-24-2021 10:57:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-24-2021 10:57:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry: Transcription Error
Feb-24-2021 10:47:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical As per CRF
CG 8.50.2.5, the
toxicity grade for
“Exposure During
Pregnancy” is
reported as Not
Applicable
Feb-24-2021 10:03:02
(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.
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141128
Page 123 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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-25-2021 09:29:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Feb-24-2021 10:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Feb-24-2021 10:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 10:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOChanged
Information
Feb-24-2021 10:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical As per CRF
CG 8.50.2.5, an
“Exposure During
Pregnancy” is not
an SAE [despite
using similar forms
to report
pregnancy]; only
abnormal outcomes
of pregnancy are
evaluated for
serious criteria
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Exposure
during pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Is this serious event associated
with congenital anomaly or birtInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141129
Page 124 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YES
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 10:03:02
(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 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141130
Page 125 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
OTHER
If Other, specify:
Unrelated
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-24-2021 10:03:02
(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 10:03:02
(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 10:03:02
(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-25-2021 08:19:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Priyanka
Nigade
(pfe nigadp)Query 1: Closed Response satisfies
query
Feb-24-2021 10:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered Pregnancy still
continuing,
unknown outcome
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141131
Page 126 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
provided or "Is the
adverse event still
ongoing?" is
marked "Yes".
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-24-2021 10:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141132
Page 127 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020 13:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141133
Page 128 of 155
***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: 10151071 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-21-2020 13:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed t
o have received only placebo a
t Vaccination 1/2Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141134
Page 129 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020 13:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141135
Page 130 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-21-2020 13:50:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/21/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141136
Page 131 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-21-2020 13:50:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-21-2020 13:50:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-21-2020 13:50:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141137
Page 132 of 155
***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: 10151071 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-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141138
Page 133 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-21-2020 13:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141139
Page 134 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-22-2020 10:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 10:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 10:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 10:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-22-2020 10:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-22-2020 10:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5CSInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141140
Page 135 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Dec-22-2020 10:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5CSInitial Entry
5.b
Date Location User Value Reason
Dec-22-2020 10:56:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5D2Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-22-2020 10:56:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5D2Initial Entry
5.c
Date Location User Value Reason
Dec-22-2020 10:56:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSN5D3Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-22-2020 10:56:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSN5D3Initial Entry
5.d
Date Location User Value Reason
Dec-22-2020 11:25:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKMZInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141141
Page 136 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Dec-22-2020 11:25:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKMZInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141142
Page 137 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-22-2020 11:54:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 11:54:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 11:54:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 11:54:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-22-2020 11:54:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-22-2020 11:54:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKMPInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141143
Page 138 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Dec-22-2020 11:54:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKMPInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141144
Page 139 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/21/2020 13:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141145
Page 140 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Route:
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-21-2020 13:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141146
Page 141 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-24-2021
18:05:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Feb-24-2021
10:05:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-24-2021
10:05:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Data
Entry
:
Dec/1
5/202
0Transcription Error
Feb-24-2021
02:17:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query
1: Rei
ssued:
Opene
dDM: Per response,
DISPOSITION CRF
unfrozen. Kindly
review and update.
Feb-23-2021
13:04:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Query
1: An
swere
dplease unfreeze
disposition so i can
update, thanks
Feb-23-2021
00:44:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7351185;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141147
Page 142 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Dec-21-2020
13:50:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Data
Entry
:
Dec/1
4/202
0Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-21-2020 13:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141148
Page 143 of 155
***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: 10151071 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-11-2021 13:35:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/11/2021Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141149
Page 144 of 155
***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: 10151071 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-11-2021 13:36:00
(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-11-2021 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-11-2021 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/11/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-11-2021 13:36:00
(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-11-2021 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-11-2021 13:36:00
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141150
Page 145 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jan-11-2021 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-11-2021 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-11-2021 13:36:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141151
Page 146 of 155
***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: 10151071 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-15-2021 12:30:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-15-2021 12:30:10
(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-15-2021 12:31:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Jan/11/2021Transcription Error
Jan-15-2021 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 12:30:10
(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-15-2021 12:30:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Jan/12/2021Initial Entry
5.a
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141152
Page 147 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Jan-15-2021 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRFKRYInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-15-2021 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BRFKRYInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141153
Page 148 of 155
***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: 10151071 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-11-2021 13:36:19
(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-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/11/2021 11:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141154
Page 149 of 155
***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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Route:
Date Location User Value Reason
Jan-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-11-2021 13:36:19
(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
Jan-11-2021 13:36:19
(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
Jan-11-2021 13:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141155
Page 150 of 155
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
00:45:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kiran Potdar
(pfe.potdak02)Query 1:
ClosedPer site
confirmation_PD
tracker updated
Mar-05-2021
09:28:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Query 1:
Answere
dCould not contact
patient until this
day. PD logged
Mar-05-2021
03:41:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 1:
OpenedPDQ: Date of
visit
V103_MONTH1
is out of window
for 1 days from
V102_VAX4
DOV or
Vaccination date.
Please verify and
update. Else,
confirm in query
response
appropriately.
"[rajkun
SDQ=150143]"
Mar-04-2021
10:47:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Data Ent
ry:
Feb/16/2
021Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141156
Page 151 of 155
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-04-2021 10:47:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-04-2021 10:47:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Contact:
Feb/16/2021Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141157
Page 152 of 155
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 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
Mar-05-2021
03:27:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clos
edAuto closed by
Validation Check:
VC_DS001_21
Mar-04-2021
18:27:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW7601968;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Mar-04-2021
10:47:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Taylor Stannard
(pfe.tstannard)Data E
ntry:
Feb/16/
2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-04-2021 10:47:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-04-2021 10:47:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141158
Page 153 of 155
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020 15:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020 11:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-20-2020 11:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-04-2021 15:52:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Donna Brandt-
VanBlarcom
(pfe.brandd01)Query 2: Closed Response satisfies
query
Mar-04-2021 10:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 2: Answered Changed data per
query
Mar-04-2021 02:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Natasha
Rajkumar
(pfe.rajkun)Query 2: Opened DM: V103 overdue
based on expected
visit window. Please
enter data or, if visit
will never occur,
mark Date of Visit as
Not Done with form
level comment. If
subject is no longer
in the trial, complete
the Disposition FUP
form & Disposition-
Treatment(EOT2)
Feb-24-2021 10:47:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141159
Page 154 of 155
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-24-2021 10:08:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answered Changed data per
query
Feb-22-2021 09:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL - a PG
safety report
(2021168713) has be
submitted; however,
the event 'Exposure
during Pregnancy'
has not been reported
on the AE CRF;
please update AE
CRF
Oct-09-2020 15:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Aug-20-2020 11:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
Aug-20-2020 11:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141160
Page 155 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151071 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-20-2020 20:03:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Elizabeth
Barnett
(pfe.ebarnett)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fe5\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141161