Document text
Page 1 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132645
Page 2 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/4/2020
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132646
Page 3 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [10071443]
2.Birth Date: /2003
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:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132647
Page 4 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132648
Page 5 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132649
Page 6 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathNov/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132650
Page 7 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Depression]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Anxiety]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Insomnia]
Start Date: UNK/UNK/2016
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Acne]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132651
Page 8 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132652
Page 9 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
2.Weight: [53.2]
3.Unit: kg
4.Height: [161.0]
5.Unit: cm
6.Body Mass Index: [20.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132653
Page 10 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS Comments
2.Lab Sub-Panel: PREGNANCY Comments
3.Collection Date: Nov/4/2020 Comments
4.Laboratory Name and Address
(Derived)[STUDY SITE] Comments
5.Specimen Type: URINE Comments
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE Comments
Not Done: Comments
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132654
Page 11 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/4/2020
2.Randomization Number: [115649]
3.Randomization Group: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132655
Page 12 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BPYVBB]
5.bSample ID [BMRW56]
5.cSample ID [BMRW57]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132656
Page 13 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BPYVB9]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132657
Page 14 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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/4/2020 14:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132658
Page 15 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132659
Page 16 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/25/2020
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132660
Page 17 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Nov/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132661
Page 18 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/25/2020
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:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132662
Page 19 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/25/2020
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 [BP90D7]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132663
Page 20 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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/25/2020 09:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132664
Page 21 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132665
Page 22 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP90ZN]
5.bSample ID [BMNR2V]
5.cSample ID [BMNR2W]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132666
Page 23 of 157
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132667
Page 24 of 157
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132668
Page 25 of 157
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132669
Page 26 of 157
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132670
Page 27 of 157
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132671
Page 28 of 157
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132672
Page 29 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132673
Page 30 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132674
Page 31 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132675
Page 32 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132676
Page 33 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 Grand Mal Seizu
re Nov/29/2020 UNK:U
NK NO
End Date Time:
Nov/29/2020 UNK:UNK
Repeating
Pages
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132677
Page 34 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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)[Grand Mal Seizure]
4.Start Date Time: Nov/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/29/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related as have additional data now showing relatedness to other cause]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132678
Page 35 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132679
Page 36 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132680
Page 37 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132681
Page 38 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132682
Page 39 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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: //
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132683
Page 40 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132684
Page 41 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132685
FDA-CBER-2021-5683-0132686
Page 43 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132687
FDA-CBER-2021-5683-0132688
Page 45 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132689
Page 46 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132690
Page 47 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132691
Page 48 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132692
Page 49 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132693
Page 50 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132694
Page 51 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132695
Page 52 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132696
Page 53 of 157
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132697
Page 54 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132698
Page 55 of 157
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/25/2020
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132699
Page 56 of 157
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132700
Page 57 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132701
Page 58 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132702
Page 59 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132703
Page 60 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132704
Page 61 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132705
Page 62 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/24/2021
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132706
Page 63 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132707
Page 64 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/24/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132708
Page 65 of 157
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/24/2021
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:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132709
Page 66 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR100L]
5.bSample ID [BSB79L]
5.cSample ID [BSB79M]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132710
Page 67 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR100K]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132711
Page 68 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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/24/2021 11:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132712
Page 69 of 157
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132713
Page 70 of 157
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132714
Page 71 of 157
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132715
Page 72 of 157
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132716
Page 73 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132717
Page 74 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132718
Page 75 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132719
Page 76 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132720
Page 77 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132721
Page 78 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132722
Page 79 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132723
Page 80 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/21/2020
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132724
Page 81 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132725
Page 82 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Frenck Approved Mar-10-2021 14:45:57 (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.
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132726
Page 83 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-04-2020 14:04:37 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132727
Page 84 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
FormNov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132728
Page 85 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
1Nov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132729
Page 86 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
2Nov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132730
Page 87 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
3Nov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132731
Page 88 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
4Nov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132732
Page 89 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Nov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
5Nov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132733
Page 90 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aNov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
6.aNov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132734
Page 91 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aNov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
6.aNov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132735
Page 92 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aNov-06-2020 10:59:01 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
6.aNov-04-2020 14:31:21 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132736
Page 93 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormFeb-24-2021 10:55:02 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132737
Page 94 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Frenck Approved Mar-10-2021 14:45:57 (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.
Laura Pace N/A Feb-24-2021 10:53:44 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Jan-23-2021 20:18:36 (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.
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132738
Page 95 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-04-2020 13:49:49
(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
Nov-04-2020 13:49:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132739
Page 96 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-04-2020 13:49:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/4/2020Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132740
Page 97 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-04-2020 13:49:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071443Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-04-2020 13:49:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/2003Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-04-2020 13:50:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-04-2020 13:50:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-04-2020 13:50:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132741
Page 98 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-04-2020 14:04:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/4/2020Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132742
Page 99 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-04-2020 14:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-04-2020 14:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-04-2020 14:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132743
Page 100 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Nov-04-2020 14:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Depression
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-04-2020 14:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 14:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
DepressionInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-04-2020 14:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-04-2020 14:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Nov-04-2020 14:29:43 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132744
Page 101 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:Anxiety
Start Date: UNK/UNK/20
17
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Nov-04-2020 14:29:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 14:29:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-04-2020 14:29:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-04-2020 14:29:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Nov-04-2020 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Insomnia
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132745
Page 102 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
1.c Line/MH Number:
Date Location User Value Reason
Nov-04-2020 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
InsomniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-04-2020 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-04-2020 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Nov-04-2020 14:30:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Acne
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132746
Page 103 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
1.d Line/MH Number:
Date Location User Value Reason
Nov-04-2020 14:30:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-07-2020 19:20:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Xiaoxia
Liu
(pfe xiaoxl)Query 1: Closed Response satisfies
query
Nov-06-2020 10:59:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered updated
Nov-05-2020 20:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Xiaoxia
Liu
(pfe xiaoxl)Query 1: Opened ClinQuery: v1: Please
can you update the
medhx log to indicate
why a pregnancy test
was not done for this
subject? There is
nothing to currently
indicate she is not a
WOBCP. Thanks
Nov-04-2020 14:30:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
AcneInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-04-2020 14:30:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-04-2020 14:30:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132747
Page 104 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-04-2020 14:30:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
The subject is NOT known to be HIV P
OSITIVEInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132748
Page 105 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
53.2Initial Entry
3. Unit:
Date Location User Value Reason
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-04-2020 14:56:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-04-2020 14:56:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
161.0Changed Information
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Height 61 is outside of
Normal Range 140 -
198 for cm or 55 - 80
for in.
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-04-2020 14:31:09
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
cmInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132749
Page 106 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
6. Body Mass Index:
Date Location User Value Reason
Nov-04-2020 14:56:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20.5Changed Information
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
143.0Initial Entry
7.a
Date Location User Value Reason
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-04-2020 14:31:09
(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
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132750
Page 107 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Nov-04-2020 14:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132751
Page 108 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/4/2020Initial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132752
Page 109 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Identi
fier:113
Test:: Not Applica
ble
Result:: NEGATIVE
Not Done::Initial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sponsor-Defined Identi
fier:
Test:: Not Applica
ble
Result::
Not Done::Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sponsor-Defined Identi
fier:Not Applica
bleInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132753
Page 110 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Test:: Not Applica
ble
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Nov-06-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
Nov-06-2020 10:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-06-2020 10:59:01
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132754
Page 111 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
Nov-04-2020 14:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132755
Page 112 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-04-2020 14:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-04-2020 14:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
115649Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132756
Page 113 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 14:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 14:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 14:38:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-04-2020 14:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-04-2020 14:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
Nov-04-2020 14:38:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYVBBInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-04-2020 14:38:20
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Jesse
LePageData Entry:
BPYVBBInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132757
Page 114 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) (pfe.jlepage)
5.b
Date Location User Value Reason
Nov-04-2020 14:38:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRW56Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-04-2020 14:38:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRW56Initial Entry
5.c
Date Location User Value Reason
Nov-04-2020 14:38:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRW57Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-04-2020 14:38:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRW57Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132758
Page 115 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 14:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 14:34:38
(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-04-2020 14:37:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-04-2020 14:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-04-2020 14:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
Nov-04-2020 14:37:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYVB9Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-04-2020 14:37:44
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Jesse
LePageData Entry:
BPYVB9Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132759
Page 116 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) (pfe.jlepage)
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132760
Page 117 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-04-2020 14:55:27
(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-04-2020 14:55:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-04-2020 14:55:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-04-2020 14:55:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/4/2020 14:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-04-2020 14:55:27
(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-04-2020 14:55:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132761
Page 118 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Nov-04-2020 14:55:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-04-2020 14:55:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-04-2020 14:55:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132762
Page 119 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-04-2020 14:55:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132763
Page 120 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-25-2020 09:29:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/25/2020Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132764
Page 121 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Nov-25-2020 09:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/25/2020Initial Entry
2.a
Date Location User Value Reason
Nov-25-2020 09:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-25-2020 09:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-25-2020 09:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-25-2020 09:29:40
(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-25-2020 09:29:40
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132765
Page 122 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132766
Page 123 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-25-2020 09:29:49
(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-25-2020 09:29:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-25-2020 09:29:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-25-2020 09:29:49
(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-25-2020 09:29:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-25-2020 09:29:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132767
Page 124 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-25-2020 09:29:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-25-2020 09:29:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-25-2020 09:29:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132768
Page 125 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020 09:29:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020 09:29:59
(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-25-2020 11:02:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-25-2020 09:29:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-25-2020 09:29:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Nov/25/2020Initial Entry
5.a
Date Location User Value Reason
Nov-25-2020 11:02:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP90D7Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-25-2020 11:02:19
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Jesse
LePageData Entry:
BP90D7Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132769
Page 126 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) (pfe.jlepage)
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132770
Page 127 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-25-2020 10:04:10
(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-25-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-25-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-25-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/25/2020 09:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-25-2020 10:04:10
(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-25-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132771
Page 128 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Nov-25-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-25-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-25-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132772
Page 129 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User ValueReason
Dec-29-2020
02:11:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Avinash Gawas
(pfe.gawasa)Query
1: Clo
sedClosed per SITE response,
added to PD tracker for
Clinical Review
Dec-28-2020
08:57:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Query
1: Ans
weredprotocol deviation was
submitted
Dec-23-2020
02:19:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 2 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. "[naikp09
SDQ=84993]"
Dec-21-2020
14:20:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Data
Entry
:
Dec/2
1/202
0Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132773
Page 130 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-21-2020 14:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-21-2020 14:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-21-2020 15:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-21-2020 14:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-21-2020 14:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-21-2020 15:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP90ZNInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-21-2020 15:54:49
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Jesse
LePageData Entry:
BP90ZNInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132774
Page 131 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) (pfe.jlepage)
5.b
Date Location User Value Reason
Dec-21-2020 15:55:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMNR2VInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-21-2020 15:55:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMNR2VInitial Entry
5.c
Date Location User Value Reason
Dec-21-2020 15:55:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMNR2WInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-21-2020 15:55:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMNR2WInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132775
Page 132 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Form Created
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132776
Page 133 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-01-2020 19:22:27
(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
Dec-28-2020 11:48:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 3: Closed Response satisfies
query
Dec-28-2020 08:11:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 3: Answered completed on CRF
Dec-15-2020 12:15:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 3: Reissued:Opened clinical: Thank you.
pls consider adding
information regarding
MRI findings under
causality.
Dec-15-2020 10:52:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 3: Answered updated relatedness
Dec-13-2020 11:10:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 3: Reissued:Opened clin: in view of
additional info from
PI re 'Multiple
well-defined rounded
foci of non-enhancing
increased signal
intensity .. within the
left medial cerebellar
hemisphere' seen on
MRI, please review
relatedness and update
if appropriate.
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132777
Page 134 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Dec-12-2020 09:44:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 3: Answered Because we don't have
alternate etiology we
are attributing to
vaccine. As participant
had no reactogenicity
prior to seizure I don’t
think it is due to the
vaccine. However, due
to lack of alternative
etiology, I think, I
have to say event is
associated
Dec-09-2020 11:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 3: Opened clin: confirming: per
PI, parents (both
MDs) witnessed pt w/
3 min general tonic
clonic sz. Pt
completely well for 4
days post vax until
this event. She was
seen in ED and
discharged w/ f/u in sz
clinic. In absence of
other etiol. PI deems
AE 'related'
Dec-09-2020 08:30:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 2: Closed Response satisfies
query
Dec-08-2020 23:35:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered subject went to the
emergency room
Dec-07-2020 14:17:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 2: Opened clinical: pls advise
where eg ED/clinic
and by whom the
diagnosis of grand mal
seizure was made.
Thanks
Dec-03-2020 08:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe.mcleol03)Query 1: Closed Response satisfies
query
Dec-02-2020 20:27:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered subject's mother
denied any history of
seizure
Dec-02-2020 20:04:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe.mcleol03)Query 1: Opened GPD Clin: please
clarify if patient
does/does not have
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132778
Page 135 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
known seicures at
baseline and update
medhx terms as
appropriate
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Grand Mal SeizureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/29/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Nov/29/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-05-2020 04:30:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe.mcleol03)Query 1: Closed Response satisfies
query
Dec-03-2020 20:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered PI does not think this
event qualifies as an
SAE
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132779
Page 136 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Dec-03-2020 08:51:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe.mcleol03)Query 1: Reissued:Opened GPD Clin:although
participant not
hospitalized, new
onset Grand Mal
Seizure could be
considered SAE as a
Medically Important
Event. Please consider
submitting SAE report
with full narrative for
event
Dec-02-2020 20:21:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered subject was not
hospitalized
Dec-02-2020 20:08:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe.mcleol03)Query 1: Opened GPD Clin: please
confirm that
participant did NOT
Require
hospitalization for the
AE grand mal seizure
Dec-01-2020 19:22:27
(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
Dec-03-2020 08:57:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Closed issued on incorrect
field
Dec-03-2020 08:53:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Opened GPD Clin: Please
provide results of
evaluation (toxicity
screen, head CT/MRI,
neurologist
evaluation, etc.) when
available
Dec-01-2020 19:22:27
(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
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132780
Page 137 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Dec-17-2020 00:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Usha Ogirala
(pfe.ogirau)Query 4: Closed Response satisfies
query
Dec-16-2020 10:05:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Changed Information
Dec-16-2020 10:05:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
Not related as have additional
data now showing relatedness t
o other causeChanged Information
Dec-16-2020 01:20:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 4: Opened DM: The response for
"If Not Related to
study treatment(s),
this event is due to is
reported as "Other",
however specify is
missing? kindly
review and update.
Dec-15-2020 10:46:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHERNew Information
Dec-07-2020 19:49:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 3: Closed Response satisfies
query
Dec-04-2020 12:50:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 3: Answered there is no alternate
etiology at this point
so it had to be called
related per PI
Dec-03-2020 21:49:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 2: Closed Response satisfies
query
Dec-03-2020 21:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 3: Opened ClinQuery: Grand
Mal Seizure : please
can you confirm why
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132781
Page 138 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
the PI felt this AE was
related to IP? Thanks
Dec-03-2020 20:05:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered There were no
symptoms that could
be associated with
COVID or other
infection
Dec-03-2020 08:56:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 2: Opened GPD Clin:Was event
accompanied by other
symptoms which
could be associated
with COVID or other
infection (URI
symptoms, fever,
etc.)? Please consider
scheduling for
COVID illness visit.
Dec-03-2020 08:54:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Closed reissuing as modified
query
Dec-02-2020 20:09:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Opened GOD clin: Did
participant have an
evaluation that ruled
other causes for gran
mal seixure
(EEG/brian scan
findings, evaluation
for febrile seizures,
etc.)?
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-01-2020 19:22:27
(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
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132782
Page 139 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-15-2020 20:55:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Closed query withdrawn
Dec-11-2020 12:42:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Reissued:Opened GPD Clin: please
update medhx terms
to include findings
from evaluation or
final diagnosis when
available (ie.
abnormal EEG,
intracranial lesions,
etc.)
Dec-03-2020 20:04:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered toxicity screen was
not done; will provide
results of other
evaluations when
received
Dec-03-2020 08:58:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Opened GPD Clin: Please
provide results of
evaluation (toxicity
screen, head CT/MRI,
neurologist
evaluation, etc.) when
available
Dec-01-2020 19:22:27
(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
Dec-03-2020 21:49:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Closed Response satisfies
query
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132783
Page 140 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-03-2020 14:49:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered none reported
Dec-02-2020 20:10:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lisa McLeod
(pfe mcleol03)Query 1: Opened GPD Clin: please
confirm that no drug
or non-drug
treatment was given
for the AE grand mal
seizure
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-01-2020 19:22:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132784
Page 141 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-21-2020 14:20:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Dec/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-21-2020 14:20:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-21-2020 14:20:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132785
Page 142 of 157
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 10:54:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Dec/25/2020Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132786
Page 143 of 157
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021 10:54:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Participant is willing to return for Vacci
nation 3
Participant is:
eligible per other protocol allowanc
e(s) and confirmed to have received
only placebo at Vaccination 1/2Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132787
Page 144 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-24-2021 10:53:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Feb/10/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-24-2021 10:53:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132788
Page 145 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 10:54:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Feb/24/2021Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132789
Page 146 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-24-2021 10:54:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/24/2021Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132790
Page 147 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-24-2021 11:16:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Feb/24/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-24-2021 11:16:44
(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-24-2021 11:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
COMPLETEDInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132791
Page 148 of 157
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-24-2021 11:51:47
(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-24-2021 11:51:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-24-2021 11:51:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Feb/24/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-24-2021 11:51:47
(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-24-2021 11:51:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-24-2021 11:51:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132792
Page 149 of 157
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Feb-24-2021 11:51:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-24-2021 11:51:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-24-2021 11:51:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132793
Page 150 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021 11:51:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021 11:51:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021 11:53:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 11:51:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-24-2021 11:51:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021 11:53:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BR100LInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021 11:53:13
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Morgan
MessederData Entry:
BR100LInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132794
Page 151 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) (pfe mmesseder)
5.b
Date Location User Value Reason
Feb-24-2021 11:53:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BSB79LInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-24-2021 11:53:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BSB79LInitial Entry
5.c
Date Location User Value Reason
Feb-24-2021 11:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BSB79MInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-24-2021 11:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BSB79MInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132795
Page 152 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021 11:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021 11:17:21
(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-24-2021 11:17:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 11:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Feb-24-2021 11:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021 11:17:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BR100KInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132796
Page 153 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Feb-24-2021 11:17:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BR100KInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132797
Page 154 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-24-2021 11:52:26
(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-24-2021 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-24-2021 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-24-2021 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Feb/24/2021 11:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-24-2021 11:52:26
(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-24-2021 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132798
Page 155 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-24-2021 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-24-2021 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-24-2021 11:52:26
(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-24-2021 11:52:26
(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
Feb-24-2021 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132799
Page 156 of 157
***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: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-21-2020 14:20:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-04-2020 14:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-04-2020 14:28:58
(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-21-2020 14:20:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/21/2020Initial Entry
Nov-04-2020 14:31:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/4/2020Initial Entry
Nov-04-2020 14:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/4/2020Initial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132800
Page 157 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071443 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-22-2021 16:30:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Click Here to EnableInitial Entry
090177e196d89035\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132801