Document text
Page 1 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132476
Page 2 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/29/2020
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132477
Page 3 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071441]
2.Birth Date: /1998
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:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132478
Page 4 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132479
Page 5 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132480
Page 6 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132481
Page 7 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132482
Page 8 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132483
Page 9 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Oct/29/2020
2.Weight: [71.7]
3.Unit: kg
4.Height: [166.0]
5.Unit: cm
6.Body Mass Index: [26.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132484
Page 10 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/29/2020
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:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132485
Page 11 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/29/2020
2.Randomization Number: [114775]
3.Randomization Group: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132486
Page 12 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
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 [BPYV91]
5.bSample ID [BMRTPN]
5.cSample ID [BMRTPP]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132487
Page 13 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
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 [BPYV8Y]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132488
Page 14 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/29/2020 15:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132489
Page 15 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132490
Page 16 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132491
Page 17 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132492
Page 18 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/19/2020
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:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132493
Page 19 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
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 [BP90CW]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132494
Page 20 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: Nov/19/2020 13:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132495
Page 21 of 169
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132496
Page 22 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BP90YF]
5.bSample ID [BMNR22]
5.cSample ID [BMNR23]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132497
Page 23 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132498
Page 24 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132499
Page 25 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132500
Page 26 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132501
Page 27 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132502
Page 28 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132503
Page 29 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132504
Page 30 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132505
Page 31 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132506
Page 32 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132507
Page 33 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Iden
tifierAdverse E
ventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Injection si
te pain Feb/19/202
1 08:00 NO
End Date Time:
Feb/22/2021 08:00
Repeating
Pages
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132508
Page 34 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[Injection site pain]
4.Start Date Time: Feb/19/2021 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/22/2021 08:00
6.Toxicity Grade: 1
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132509
Page 35 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132510
Page 36 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132511
Page 37 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132512
Page 38 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132513
Page 39 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132514
Page 40 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: //
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132515
Page 41 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132516
Page 42 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132517
Page 43 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132518
Page 44 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132519
FDA-CBER-2021-5683-0132520
Page 46 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132521
Page 47 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132522
Page 48 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132523
Page 49 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132524
Page 50 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132525
Page 51 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132526
Page 52 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132527
Page 53 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132528
Page 54 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132529
Page 55 of 169
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132530
Page 56 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132531
Page 57 of 169
***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
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132532
Page 58 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132533
Page 59 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/11/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132534
Page 60 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132535
Page 61 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132536
Page 62 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132537
Page 63 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/18/2021
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132538
Page 64 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132539
Page 65 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132540
Page 66 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/18/2021
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:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132541
Page 67 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BR0ZTX]
5.bSample ID [BNWN29]
5.cSample ID [BNWN2G]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132542
Page 68 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BR0ZV3]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132543
Page 69 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/18/2021 15:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132544
Page 70 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132545
Page 71 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/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:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132546
Page 72 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/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 [BRB5X4]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132547
Page 73 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: Mar/11/2021 15:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132548
Page 74 of 169
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132549
Page 75 of 169
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132550
Page 76 of 169
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132551
Page 77 of 169
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132552
Page 78 of 169
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132553
Page 79 of 169
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132554
Page 80 of 169
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132555
Page 81 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/17/2020
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132556
Page 82 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132557
Page 83 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132558
Page 84 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 15:57:25 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132559
Page 85 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 16:04:36 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132560
Page 86 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-18-2021 14:55:21 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132561
Page 87 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Laura Pace N/A Mar-11-2021 15:34:04 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Mar-10-2021 14:44:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, 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.
Haley Muth N/A Feb-18-2021 14:40:24 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132562
Page 88 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
N/A
Robert
Frenck Approved Jan-23-2021 20:17:38 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, 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.
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132563
Page 89 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-29-2020
15:21:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-29-2020
15:21:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132564
Page 90 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-29-2020
15:21:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent
Obtained
Oct/29/2020Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132565
Page 91 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-29-2020
15:21:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071441Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-29-2020
15:21:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1998Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-29-2020
15:22:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132566
Page 92 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-29-2020
15:22:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-29-2020
15:22:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132567
Page 93 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020
15:57:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/29/2020Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132568
Page 94 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-29-2020
15:58:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020
15:58:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020
15:58:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132569
Page 95 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-29-2020
15:59:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
The subject is NOT kn
own to be HIV POSITI
VEInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132570
Page 96 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
71.7Initial Entry
3. Unit:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132571
Page 97 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
166.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.0Initial Entry
7.a
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Ide 1Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132572
Page 98 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)ntifier::
Temperatur
e:37.1
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132573
Page 99 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-29-2020
16:03:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132574
Page 100 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132575
Page 101 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132576
Page 102 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-29-2020
15:59:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132577
Page 103 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-29-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-29-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
114775Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132578
Page 104 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020
16:00:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020
16:00:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
16:14:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
16:00:59ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132579
Page 105 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-29-2020
16:00:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
16:14:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPYV9
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
16:14:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYV91Initial Entry
5.b
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132580
Page 106 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-29-2020
16:14:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BMRTP
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020
16:14:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTPNInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020
16:14:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BMRTP
PInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132581
Page 107 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
16:14:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTPPInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132582
Page 108 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020
16:01:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020
16:01:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
16:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
16:01:07ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132583
Page 109 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-29-2020
16:01:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
16:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPYV8
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
16:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYV8YInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132584
Page 110 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132585
Page 111 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/29/2020 15:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132586
Page 112 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-29-2020
16:25:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132587
Page 113 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-29-2020
16:25:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO - REACTOGENIC
ITY E-DIARY NOT C
OLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132588
Page 114 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-19-2020
13:14:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/19/2020Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132589
Page 115 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Nov-19-2020
13:15:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-19-2020
13:15:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.9
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-19-2020
13:15:02
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132590
Page 116 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Nov-19-2020
13:15:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-19-2020
13:15:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-19-2020
13:15:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132591
Page 117 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132592
Page 118 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132593
Page 119 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-19-2020
15:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132594
Page 120 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020
13:15:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020
13:15:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020
17:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-19-2020
13:15:43ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132595
Page 121 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-19-2020
13:15:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-19-2020
17:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BP90C
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020
17:08:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BP90CWInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132596
Page 122 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132597
Page 123 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/19/2020 13:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132598
Page 124 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-19-2020
15:57:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132599
Page 125 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020
14:16:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/17/2020Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132600
Page 126 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020
14:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020
14:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020
16:31:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-17-2020
14:16:42ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132601
Page 127 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-17-2020
14:16:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020
16:31:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BP90Y
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020
16:31:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BP90YFInitial Entry
5.b
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132602
Page 128 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Dec-17-2020
16:31:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BMNR
22Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020
16:31:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BMNR22Initial Entry
5.c
Date Location User Value Reason
Dec-17-2020
16:31:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BMNR
23Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132603
Page 129 of 169
***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, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Dec-17-2020
16:31:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BMNR23Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132604
Page 130 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132605
Page 131 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021
15:34:04
(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
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection site painInitial Entry
4. Start Date Time:
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132606
Page 132 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/19/2021 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Feb/22/2021 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132607
Page 133 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021
10:51:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Katerina
Trpeski
(pfe.TRPESK)Query 1: Closed Response
satisfies query
Mar-12-2021
07:37:15
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132608
Page 134 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
Mar-12-2021
07:37:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RELATEDNew
Information
Mar-12-2021
06:05:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe.reddyr51)Query 1: Opened DM: The
response for
"Is this event
related to
study
treatment" is
missing.
Kindly review
and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021
15:34:04ACV0PFEINFP6000 Laura
PaceData Entry:
NOInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132609
Page 135 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.lpace)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
RECOVERED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021
15:34:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132610
Page 136 of 169
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-17-2020
14:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-17-2020
14:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-17-2020
14:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132611
Page 137 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
14:41:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-18-2021
14:41:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Dec/23/2020Changed
Information
Feb-18-2021
14:40:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Visit,
23/Dec/2021 is
a future date
relative to
when it was
entered on
18/Feb/2021.
Please correct.
Feb-18-2021
14:40:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Dec/23/2021Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132612
Page 138 of 169
***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
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
14:41:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible per other p
rotocol allowance(
s) and confirmed to
have received only
placebo at Vaccinat
ion 1/2Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132613
Page 139 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021
14:40:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Feb/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-18-2021
14:40:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132614
Page 140 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
14:41:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Feb/18/2021Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132615
Page 141 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-18-2021
14:55:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
OBTAINED
Date Written Consen
t Obtained
Feb/18/2021Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132616
Page 142 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-18-2021
18:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-18-2021
18:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-18-2021
18:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132617
Page 143 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/18/2021Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132618
Page 144 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132619
Page 145 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-18-2021
18:44:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132620
Page 146 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021
18:44:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021
18:44:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
08:54:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-19-2021
06:27:20ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132621
Page 147 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-18-2021
18:44:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-18-2021
18:44:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021
08:54:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BR0ZT
XInitial Entry
5.a Sample ID
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132622
Page 148 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-19-2021
08:54:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BR0ZTXInitial Entry
5.b
Date Location User Value Reason
Feb-19-2021
08:54:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BNWN
29Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-19-2021
08:54:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BNWN29Initial Entry
5.c
Date Location User Value Reason
Feb-19-2021
08:54:35
(UTC-05:00)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I BNWNInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132623
Page 149 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)D: 2G
5.c Sample ID
Date Location User Value Reason
Feb-19-2021
08:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BNWN2GInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132624
Page 150 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021
18:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021
18:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
08:47:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-19-2021
06:27:20ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132625
Page 151 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-18-2021
18:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-18-2021
18:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021
08:47:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BR0ZV
3Initial Entry
5.a Sample ID
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132626
Page 152 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-19-2021
08:47:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BR0ZV3Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132627
Page 153 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132628
Page 154 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/18/2021 15:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132629
Page 155 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-18-2021
18:45:08
(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
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132630
Page 156 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-18-2021
18:45:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132631
Page 157 of 169
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021
16:20:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
Mar/11/2021Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132632
Page 158 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
Mar/11/2021Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132633
Page 159 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132634
Page 160 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Mar-11-2021
16:20:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
NEGATIVEInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132635
Page 161 of 169
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-11-2021
15:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-11-2021
15:44:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021
15:45:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-11-2021
15:44:49ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132636
Page 162 of 169
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time
(US & Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-11-2021
15:44:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
YES
Date of Collecti
on:
Mar/11/2021Initial Entry
5.a
Date Location User Value Reason
Mar-11-2021
15:45:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample I
D:BRB5
X4Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-11-2021
15:45:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
BRB5X4Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132637
Page 163 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132638
Page 164 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
Mar/11/2021 15:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132639
Page 165 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8. Actual Dose:
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-11-2021
16:21:13
(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
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132640
Page 166 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Mar-11-2021
16:21:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Yislain
Villalona
(pfe.yvillalona)Data Entry:
YESInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132641
Page 167 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-17-2020
14:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-29-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-29-2020
15:58:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-17-2020
14:17:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/17/2020Initial Entry
Oct-29-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132642
Page 168 of 169
***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) Oct/29/2020
Oct-29-2020
15:58:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132643
Page 169 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071441 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-22-2021
16:30:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Click Here to EnableInitial Entry
090177e196ae401f\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132644