Document text
Page 1 of 172
***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: 10071315 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132123
Page 2 of 172
***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: 10071315 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
Oct/13/2020
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132124
Page 3 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [10071315]
2.Birth Date: /1946
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132125
Page 4 of 172
***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: 10071315 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 Oct/13/2020
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132126
Page 5 of 172
***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: 10071315 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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132127
Page 6 of 172
***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: 10071315 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
/DeathOct/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132128
Page 7 of 172
***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: 10071315 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:[Hypertension]
Start Date: UNK/UNK/1978
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 diabetes mellitus]
Start Date: UNK/UNK/1991
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High cholesterol]
Start Date: UNK/UNK/1986
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastrooesophageal reflux disease]
Start Date: UNK/UNK/1978
Ongoing: YES
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132129
Page 8 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Deviated septum repair]
Start Date: UNK/UNK/1986
Ongoing: NO
End Date:
UNK/UNK/1986
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ethmoid sinus surgery]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ethmoid sinus surgery]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sulfonamide allergy]
Start Date: UNK/UNK/1996
Ongoing: YES
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132130
Page 9 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar discectomy]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herniated disc]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132131
Page 10 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
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 Comments
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132132
Page 11 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
2.Weight: [78.0]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [27.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132133
Page 12 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/13/2020
2.Randomization Number: [268813]
3.Randomization Group: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132134
Page 13 of 172
***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: 10071315 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:
Oct/13/2020
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 [BPYTZH]
5.bSample ID [BMRTC4]
5.cSample ID [BMRTC5]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132135
Page 14 of 172
***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: 10071315 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:
Oct/13/2020
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 [BPYTZF]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132136
Page 15 of 172
***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: 10071315 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: Oct/13/2020 11:51
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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132137
Page 16 of 172
***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: 10071315 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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132138
Page 17 of 172
***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: 10071315 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/14/2020
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132139
Page 18 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Dec/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132140
Page 19 of 172
***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: 10071315 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:
Dec/14/2020
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 [BP90VL]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132141
Page 20 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 10071315 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?YES
Date of First Delay:
Nov/3/2020
Reason(s) for Temporary Delay of Vaccination
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/14/2020 11:13
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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132142
Page 21 of 172
***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: 10071315 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 Jan/14/2021
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132143
Page 22 of 172
***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: 10071315 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:
Jan/14/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRB8MJ]
5.bSample ID [BNWMMR]
5.cSample ID [BNWMMS]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132144
Page 23 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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:
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132145
Page 24 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132146
Page 25 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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 [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132147
Page 26 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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 [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132148
Page 27 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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?
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132149
Page 28 of 172
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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:
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132150
Page 29 of 172
***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: 10071315 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:
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132151
Page 30 of 172
***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: 10071315 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 [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132152
Page 31 of 172
***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: 10071315 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:
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132153
Page 32 of 172
***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: 10071315 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 [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132154
Page 33 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 hearing loss Nov/1/2020 UNK:
UNK NO
End Date Time:
Jan/20/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 Injection site sore
ness Jan/19/2021 16:00 NO
End Date Time:
Jan/20/2021 UNK:UNK
Repeating
Pages
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132155
Page 34 of 172
***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: 10071315 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)[hearing loss]
4.Start Date Time: Nov/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[injury due recreational firearm noise exposure]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132156
Page 35 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132157
Page 36 of 172
***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: 10071315 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection site soreness]
4.Start Date Time: Jan/19/2021 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132158
Page 37 of 172
***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: 10071315 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[ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132159
Page 38 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132160
Page 39 of 172
***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: 10071315 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[ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132161
Page 40 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132162
Page 41 of 172
***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: 10071315 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: //
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132163
Page 42 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. DELETED 1 CORTICOSTE
ROIDS NO Prednisone 60 Repeating
Pages
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132164
Page 43 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Prednisone ]
5.Dose: [60]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Nov/2/2020
10.Ongoing? NO
End Date:
Nov/12/2020
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132165
FDA-CBER-2021-5683-0132166
Page 45 of 172
***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: 10071315 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?
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132167
FDA-CBER-2021-5683-0132168
Page 47 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132169
Page 48 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132170
Page 49 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132171
Page 50 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132172
Page 51 of 172
***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: 10071315 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:
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132173
Page 52 of 172
***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: 10071315 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?
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132174
Page 53 of 172
***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: 10071315 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: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132175
Page 54 of 172
***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: 10071315 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: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132176
Page 55 of 172
***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: 10071315 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 :Jan/14/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132177
Page 56 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132178
Page 57 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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 local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132179
Page 58 of 172
***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: 10071315 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: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132180
Page 59 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132181
Page 60 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132182
Page 61 of 172
***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: 10071315 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: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132183
Page 62 of 172
***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: 10071315 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 Jan/19/2021
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132184
Page 63 of 172
***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: 10071315 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
Jan/19/2021
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132185
Page 64 of 172
***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: 10071315 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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132186
Page 65 of 172
***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: 10071315 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 :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132187
Page 66 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[samples were collected on 14JAN2021 as Visit 3]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRB8MJ ]
5.bSample ID [BNWMMR ]
5.cSample ID [BNWMMS ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132188
Page 67 of 172
***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: 10071315 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:
Jan/19/2021
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 [BRB8N6]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132189
Page 68 of 172
***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: 10071315 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: Jan/19/2021 10:11
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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132190
Page 69 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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/9/2021
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132191
Page 70 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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/9/2021
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 [BRB94V]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132192
Page 71 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10071315 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/9/2021 12:57
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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132193
Page 72 of 172
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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 Mar/9/2021
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132194
Page 73 of 172
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/9/2021
3.Comments: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132195
Page 74 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132196
Page 75 of 172
***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: 10071315 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: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132197
Page 76 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132198
Page 77 of 172
***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: 10071315 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: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132199
Page 78 of 172
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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 :Mar/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132200
Page 79 of 172
***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: 10071315 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 Jan/14/2021
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132201
Page 80 of 172
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Casebook Signature Form
1.Casebook Signature
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132202
Page 81 of 172
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10071315 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132203
Page 82 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormOct-13-2020 12:27:06 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132204
Page 83 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - Comments
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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormOct-29-2020 09:10:03 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)
FormOct-13-2020 14:13:37 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132205
Page 84 of 172
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - Comments
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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Oct-29-2020 09:10:03 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)
1Oct-13-2020 14:13:37 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132206
Page 85 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-19-2021 09:47:38 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132207
Page 86 of 172
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-21-2021 08:03:53 (UTC-05:00) Eastern
Time (US & Canada)Jesse LePage
(pfe.jlepage)these serum specimens were also for Visit 3
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132208
Page 87 of 172
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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: 10071315 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132209
Page 88 of 172
***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: 10071315 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
Oct-13-2020 12:23:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-13-2020 12:23:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132210
Page 89 of 172
***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: 10071315 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
Oct-13-2020 12:26:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/13/2020Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132211
Page 90 of 172
***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: 10071315 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
Oct-13-2020 12:23:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071315Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-13-2020 12:23:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-13-2020 12:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-13-2020 12:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-13-2020 12:26:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132212
Page 91 of 172
***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: 10071315 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
Oct-13-2020 12:26:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/13/2020Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132213
Page 92 of 172
***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: 10071315 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
Oct-13-2020 12:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020 12:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020 12:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132214
Page 93 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Oct-13-2020 14:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Hypertension
Start Date: UNK/UNK/1
978
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:14:25
(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
Oct-13-2020 14:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-13-2020 14:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1978Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-13-2020 14:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132215
Page 94 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Oct-13-2020 14:14:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Type 2 diabetes
mellitus
Start Date: UNK/UNK/1991
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:14:57
(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
Oct-13-2020 14:14:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Type 2 diabetes mellitusInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-13-2020 14:14:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1991Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-13-2020 14:14:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-13-2020 14:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132216
Page 95 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Medical History Te
rm:High cholester
ol
Start Date: UNK/UNK/1
986
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:15:32
(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
Oct-13-2020 14:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
High cholesterolInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-13-2020 14:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1986Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-13-2020 14:15:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-13-2020 14:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:Gastrooesophageal
reflux disease
Start Date: UNK/UNK/1978Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132217
Page 96 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:16:07
(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
Oct-13-2020 14:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Gastrooesophageal reflux diseaseInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-13-2020 14:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1978Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-13-2020 14:16:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-13-2020 14:16:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Deviated septum
repair
Start Date: UNK/UNK/1986Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132218
Page 97 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Ongoing: NO
End Date:
UNK/UNK/19
86
1.e Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:16:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 14:16:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Deviated septum repairInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-13-2020 14:16:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1986Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-13-2020 14:16:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1986Initial Entry
1.f
Date Location User Value Reason
Oct-13-2020 14:17:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Ethmoid sinus su
rgeryInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132219
Page 98 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1
988
1.f Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:17:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 14:17:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Ethmoid sinus surgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-13-2020 14:17:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1988Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-13-2020 14:17:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.g
Date Location User Value Reason
Oct-13-2020 14:18:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132220
Page 99 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Medical History
Term:Ethmoid sinus su
rgery
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1
991
1.g Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:18:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 14:18:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Ethmoid sinus surgeryInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-13-2020 14:18:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1991Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-13-2020 14:18:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
1.h
Date Location User Value Reason
Oct-13-2020 14:19:05
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number 8Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132221
Page 100 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) :
Medical History T
erm:Sulfonamide all
ergy
Start Date: UNK/UNK/199
6
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:19:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 14:19:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sulfonamide allergyInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-13-2020 14:19:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1996Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-13-2020 14:19:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-13-2020 14:20:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Lumbar discect
omyInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132222
Page 101 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Start Date: UNK/UNK/199
6
Ongoing: NO
End Date:
UNK/UNK/1
996
1.i Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:20:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 14:20:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Lumbar discectomyInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-13-2020 14:20:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1996Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-13-2020 14:20:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
1.j
Date Location User Value Reason
Oct-13-2020 14:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132223
Page 102 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Medical History
Term:Herniated disc
Start Date: UNK/UNK/199
6
Ongoing: NO
End Date:
UNK/UNK/1
996
1.j Line/MH Number:
Date Location User Value Reason
Oct-13-2020 14:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 14:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Herniated discInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-13-2020 14:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1996Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-13-2020 14:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132224
Page 103 of 172
***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: 10071315 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
Oct-30-2020 01:57:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jayesh Yeole
(pfe.yeolej)Query 1: Closed Data updated.
Oct-29-2020 09:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-29-2020 09:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
Oct-29-2020 09:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Initial Entry
Oct-29-2020 08:42:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Priyanka
Mandava
(pfe.mandap12)Query 1: Opened DM: Please remove
comment and report
whether the "The
subject is known to
be HIV POSITIVE"
OR "The subject is
NOT known to be
HIV POSITIVE".
Thank you.
Oct-13-2020 14:13:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132225
Page 104 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
78.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
170.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.0Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132226
Page 105 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
7.a
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-13-2020 14:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132227
Page 106 of 172
***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: 10071315 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
Oct-13-2020 14:09:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-13-2020 14:09:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
268813Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132228
Page 107 of 172
***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: 10071315 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
Oct-13-2020 13:01:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 13:01:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 13:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 13:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-13-2020 13:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 13:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTZHInitial Entry
5.a Sample ID
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132229
Page 108 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Oct-13-2020 13:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTZHInitial Entry
5.b
Date Location User Value Reason
Oct-13-2020 13:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTC4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 13:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTC4Initial Entry
5.c
Date Location User Value Reason
Oct-13-2020 13:01:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTC5Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-13-2020 13:01:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTC5Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132230
Page 109 of 172
***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: 10071315 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
Oct-13-2020 12:40:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 12:40:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 12:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 12:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-13-2020 12:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 12:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTZFInitial Entry
5.a Sample ID
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132231
Page 110 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Oct-13-2020 12:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTZFInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132232
Page 111 of 172
***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: 10071315 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
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/13/2020 11:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132233
Page 112 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
7. Route:
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-13-2020 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132234
Page 113 of 172
***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: 10071315 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
Oct-13-2020 14:12:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132235
Page 114 of 172
***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: 10071315 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
Dec-14-2020 10:47:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/14/2020Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132236
Page 115 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Dec-14-2020 10:47:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/14/2020Initial Entry
2.a
Date Location User Value Reason
Dec-14-2020 10:47:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-14-2020 10:47:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-14-2020 10:47:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-14-2020 10:47:32
(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
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132237
Page 116 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Dec-14-2020 10:47:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132238
Page 117 of 172
***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: 10071315 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-14-2020 10:51:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-14-2020 10:51:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-14-2020 11:30:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-14-2020 10:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Dec-14-2020 10:51:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Dec/14/2020Initial Entry
5.a
Date Location User Value Reason
Dec-14-2020 11:30:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BP90VLInitial Entry
5.a Sample ID
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132239
Page 118 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Dec-14-2020 11:30:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BP90VLInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132240
Page 119 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 10071315 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
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES
Date of First Delay:
Nov/3/2020
Reason(s) for Temporary Delay of
Vaccination
RECENT SYSTEMIC CORTIC
OSTEROID TREATMENTInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/14/2020 11:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132241
Page 120 of 172
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
6. Body Side:
Date Location User Value Reason
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-14-2020 12:07:21
(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
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-14-2020 12:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132242
Page 121 of 172
***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: 10071315 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-10-2021
13:46:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Gbenga Akinkunmi
(pfe.akinkg)Query 2:
ClosedResponse satisfies
query
Feb-10-2021
07:13:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2:
Answere
dupdated
Feb-10-2021
01:56:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 2:
Reissued
:OpenedDM: Page is
unfreeze. Kindly
consider to update
correct data if
needed or else
clarify. Thank you.
Feb-09-2021
13:14:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2:
Answere
dplease unfreeze
revax_contact for
update
Jan-29-2021
00:00:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 2:
Reissued
:OpenedDM: Please verify
REVAX_CONTACT
date cannot be same
as V3. Kindly verify
data reported update
if required or else
clarify. Thank you.
Jan-27-2021
08:19:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2:
Answere
ddates are correct
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132243
Page 122 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Jan-27-2021
07:54:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Pratiksha Mahadik
(pfe mahadp07)Query 2:
OpenedDM: The Date of
Visit at Visit
‘V3POSTVX2L’ is
the same as the other
Date of Visit at Visit
‘REVAX CONT’.
Please review for
duplication and
update as
appropriate. Else
clarify.
Jan-27-2021
07:53:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Pratiksha Mahadik
(pfe mahadp07)Query 1:
ClosedQuery issued with
modified text.
Jan-27-2021
07:52:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
OpenedDMW6886198;The
Date of Visit at Visit
‘V3POSTVX2L’ is
the same as the other
Date of Visit at Visit
‘V101VAX3’. Please
review for
duplication and
update as
appropriate. Else
clarify.
Jan-14-2021
13:41:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data En
try:
Jan/14/2
021Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132244
Page 123 of 172
***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: 10071315 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
Jan-14-2021 13:42:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-14-2021 13:42:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-14-2021 13:42:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-14-2021 13:42:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-14-2021 13:42:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-14-2021 13:42:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BRB8MJInitial Entry
5.a Sample ID
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132245
Page 124 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Jan-25-2021
21:35:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
ClosedAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-25-2021
13:11:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 1:
Answere
dChanged data per
query
Jan-25-2021
00:53:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1:
Reissued
:OpenedDM: Please consider
to mark lab sample
page at Visit 101 as
No leaving comment
at field #4 as
sampling done on
V3. Thank you.
Jan-22-2021
09:55:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 1:
Answere
dserum obtained at
Visit 3 on
14JAN2021 is also
for Visit 101 which
occurred on
19JAN2021
Jan-21-2021
15:39:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
OpenedDMW6942618;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-14-2021
13:42:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data En
try:
BRB8M
JInitial Entry
5.b
Date Location User Value Reason
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132246
Page 125 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Jan-14-2021 13:42:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMMRInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-25-2021
21:35:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
ClosedAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-22-2021
09:56:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 1:
Answere
dserum obtained at
Visit 3 on
14JAN2021 is also
for Visit 101 which
occurred on
19JAN2021
Jan-21-2021
15:39:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
OpenedDMW6942616;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-14-2021
13:42:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data En
try:
BNWM
MRInitial Entry
5.c
Date Location User Value Reason
Jan-14-2021 13:42:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMMSInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132247
Page 126 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
5.c Sample ID
Date Location User Value Reason
Jan-25-2021
21:35:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
ClosedAuto closed by
Validation Check:
VC_BEETRK001_01
Jan-22-2021
09:56:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 1:
Answere
dserum obtained at
Visit 3 on
14JAN2021 is also
for Visit 101 which
occurred on
19JAN2021
Jan-21-2021
15:39:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
OpenedDMW6942617;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Jan-14-2021
13:42:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data En
try:
BNWM
MSInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132248
Page 127 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Form Created
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132249
Page 128 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Form Created
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132250
Page 129 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-09-2021 11:20:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Closed Response satisfies
query
Feb-08-2021 17:35:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered subject did not have
past history of
hearing loss
Feb-05-2021 11:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Opened clinical: pls confirm
subject has no past
history of hearing
loss or update
MedHx CRF
accordingly. Thanks
Nov-02-2020 13:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
hearing lossInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/1/2020 UNK:UNKInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132251
Page 130 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-15-2021 13:25:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Closed Response satisfies
query
Feb-15-2021 13:04:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered subject saw
audiologist and was
prescribed hearing
aids
Feb-12-2021 12:37:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Opened clinical: pls advise if
subject hearing has
returned to normal
and if so if this was
based on subject
assessment or
audiometry. Thanks
Feb-10-2021 09:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Jan/20/2021 UNK:UNKNew Information
Nov-02-2020 13:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-02-2020 13:11:09 ACV0PFEINFP6000 Laura Data Entry: Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132252
Page 131 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(UTC-05:00) Eastern Time
(US & Canada)Pace
(pfe.lpace)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.
Date Location User Value Reason
Nov-02-2020 13:11:09
(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
Nov-04-2020
07:32:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Vikas Joshi
(pfe.joshiv22)Query 1: Cl
osedResponse
satisfies query
Nov-03-2020
15:25:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredupdated
Nov-03-2020
15:25:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Data Entry:
NOT RELA
TED
If Not Rela
ted to stud
y treatment
(s), this ev
ent is due t
o:
OTHER
If Other,
specify:
injury
due re
creati
onal fi
rearm
noiseupdated
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132253
Page 132 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
expos
ure
Nov-03-2020
05:06:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 1: Op
enedPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [injury].
Any
symptoms,
AEs or other
key data should
be collected on
the appropriate
page. Please
review and
update as
necessary.
"[lv04
SDQ=36063]"
Nov-02-2020
13:11:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Data Entry:
NOT RELA
TED
If Not Rela
ted to stud
y treatment
(s), this ev
ent is due t
o:
OTHER
If Other,
specify:
injuryInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOT APPLICABLEInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132254
Page 133 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-02-2020 13:11:09
(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 ValueReason
Feb-10-2021
09:45:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Feb-10-2021
09:45:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry
:
REC
OVE
RED/
RESO
LVED
WITH
SEQU
ELAETranscription Error
Feb-10-2021
09:45:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Op
enedFor AE hearing loss:
Response to "What was
the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time is
present.
Jan-25-2021
21:18:13
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_AE001_35
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132255
Page 134 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Eastern Time
(US &
Canada)
Jan-25-2021
13:14:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Jan-25-2021
13:14:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGTranscription Error
Jan-24-2021
21:04:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Rei
ssued:
Opene
dReopen: Response to
"What was the outcome
of this adverse event?" is
'Recovered/Resolved' or
'Recovered/Resolved
with Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
Jan-24-2021
18:46:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged Information
Jan-24-2021
18:46:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry
:
REC
OVE
RED/
RESO
LVED
WITH
SEQU
ELAEChanged Information
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132256
Page 135 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Jan-20-2021
21:30:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW6912162;Response
to "What was the
outcome of this adverse
event?" is
'Recovered/Resolved' or
'Recovered/Resolved
with Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
Jan-20-2021
18:25:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry
:
REC
OVE
RED/
RESO
LVEDNew Information
Nov-02-2020
13:11:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry
:
NOT
REC
OVE
RED/
NOT
RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-02-2020 13:11:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132257
Page 136 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection site sorenessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/19/2021 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Jan/20/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132258
Page 137 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-09-2021 13:16:15
(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
Feb-09-2021 13:16:15
(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
Feb-10-2021 13:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response satisfies
query
Feb-10-2021 09:45:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-10-2021 09:45:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RELATEDInitial Entry
Feb-10-2021 01:36:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM: The response
for "Is this event
related to study
treatment" is
missing. Kindly
review and update.
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132259
Page 138 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-09-2021 13:16:15
(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
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-09-2021 13:16:15
(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
Feb-09-2021 13:16:15
(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
Feb-09-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132260
Page 139 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-18-2021 21:36:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Form Deleted Changed
Information
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Form Created
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132261
Page 140 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Jan-19-2021 19:40:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Xiaoxia Liu
(pfe xiaoxl)Query 3: Closed Response satisfies
query
Jan-18-2021 21:36:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 3: Answered deleted
Dec-03-2020 19:35:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Xiaoxia Liu
(pfe xiaoxl)Query 2: Closed Response satisfies
query
Dec-01-2020 07:22:56
(UTC-05:00) EasternACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered it was taken for AE
#1 hearing loss
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132262
Page 141 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
Nov-30-2020 23:47:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swetha
Thangellapally
(pfe.thangs22)Query 3: Opened ClinQuery:
Prednisone: Please
note this medication
does not meet the
dose/duration
criteria listed in
section 6.5.1 in order
to be listed in this
CRF. Please remove
as appropriate.
Thanks
Nov-30-2020 20:12:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Xiaoxia Liu
(pfe xiaoxl)Query 3: Candidate ClinQuery:
Prednisone: Please
note this medication
does not meet the
dose/duration
criteria listed in
section 6.5.1 in order
to be listed in this
CRF. Please remove
as appropriate.
Thanks
Nov-30-2020 20:08:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Xiaoxia Liu
(pfe xiaoxl)Query 2: Opened ClinQuery:
Prednisone: Please
can you update the
AE log to clarify the
reason why this
medication was
adminstered?
Thanks
Nov-11-2020 19:45:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Xiaoxia Liu
(pfe xiaoxl)Query 1: Closed Response satisfies
query
Nov-10-2020 15:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered protocol deviation
was completed
Nov-07-2020 06:26:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe hassaa38)Query 1: Reissued:Opened please keep the
query with you until
this information is
obtained. If this is a
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132263
Page 142 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
prohibited
medication
exceeding the
dose/duration
criteria (protocol
6.5.1) a PD will be
required. thanks
Nov-06-2020 10:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered contact subject to get
dose
Nov-04-2020 20:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Xiaoxia Liu
(pfe xiaoxl)Query 1: Opened ClinQuery:
Prednisone: please
can you update to
include the dose and
frequency of this
medication? Thanks
Nov-03-2020 18:04:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
PrednisoneInitial Entry
5. Dose:
Date Location User Value Reason
Nov-11-2020 00:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Astrud van der
Merwe
(pfe.vandea62)Query 1: Closed Response satisfies
query
Nov-10-2020 12:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Nov-10-2020 12:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
60Initial Entry
Nov-06-2020 04:46:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: Please update
incomplete item.
Thank you.
6. Dose Unit:
Date Location User Value Reason
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132264
Page 143 of 172
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Nov-05-2020 10:26:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/2/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Nov-23-2020 08:13:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Nov/12/2020New Information
Nov-03-2020 18:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132265
Page 144 of 172
***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: 10071315 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
Jan-14-2021 14:06:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/14/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-14-2021 14:06:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-14-2021 14:06:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132266
Page 145 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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-10-2021 07:13:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/25/2020Changed Information
Jan-19-2021 09:46:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/14/2021Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132267
Page 146 of 172
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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
Jan-19-2021 09:47:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible per local/national recom
mendations and confirmed to hav
e received only placebo at Vaccin
ation 1/2Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132268
Page 147 of 172
***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: 10071315 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
Jan-19-2021 09:46:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021 09:46:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132269
Page 148 of 172
***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: 10071315 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
Jan-19-2021 09:47:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/19/2021Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132270
Page 149 of 172
***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: 10071315 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
Jan-19-2021 09:47:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/19/2021Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132271
Page 150 of 172
***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: 10071315 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
Jan-19-2021 11:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 11:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021 11:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132272
Page 151 of 172
***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: 10071315 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
Jan-19-2021 11:15:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 11:15:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021
05:49:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Astrud van der
Merwe
(pfe.vandea62)Query 2:
ClosedResponse satisfies
query
Jan-25-2021
13:10:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 6:
ClosedClose Auto Query
Jan-25-2021
13:10:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 6:
OpenedResponse to
"Sample Collected?"
is No, but Barcodes
are present on the
page.
Jan-25-2021
13:10:19
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 auto query
(autoquery)Query 5:
ClosedClose Auto Query
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132273
Page 152 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Canada)
Jan-25-2021
13:10:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5:
OpenedResponse to
"Sample Collected?"
is No, but Barcodes
are present on the
page.
Jan-25-2021
13:10:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4:
ClosedClose Auto Query
Jan-25-2021
13:09:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
ClosedClose Auto Query
Jan-25-2021
13:08:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4:
OpenedResponse to
"Sample Collected?"
is No, but Barcodes
are present on the
page.
Jan-25-2021
13:08:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
Opened'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Jan-25-2021
13:08:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answere
dchanged per query
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132274
Page 153 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Jan-25-2021
13:08:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
NOchanged per query
Jan-25-2021
03:56:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Malerato Moloi
(pfe moloim)Query 2:
Reissued:
OpenedDM: Since sample
was not collected
according to
protocol, please
provide reason on
filed 4.
Jan-22-2021
09:57:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 2:
Answere
dserum obtained at
Visit 3 on
14JAN2021 is also
for Visit 101 which
occurred on
19JAN2021
Jan-21-2021
16:09:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 2:
OpenedDMW6942700;Date
of Collection is not
equal to Date of
Visit. Please clarify
or correct.
Jan-21-2021
08:01:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
ClosedClose Auto Query
Jan-21-2021
08:01:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
YES
Date of
Collecti
on:
Jan/14
/2021Changed
Information
Jan-21-2021
06:07:42
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1:
Opened'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132275
Page 154 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
(US &
Canada)review and correct
as appropriate.
Jan-19-2021
11:15:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Candidat
e'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-19-2021
11:15:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Ent
ry:
YES
Date of
Collecti
on:
Jan/19
/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-25-2021 13:09:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
samples were collected on 14JAN2
021 as Visit 3Initial Entry
5.a
Date Location User Value Reason
Jan-25-2021 13:10:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BRB8MJdeleted per query
(DELETED)
Jan-21-2021 08:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BRB8MJInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-26-2021
05:56:48
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Malerato Moloi
(pfe moloim)Query 1:
ClosedResponse satisfies
query
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132276
Page 155 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Canada)
Jan-25-2021
13:10:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
BRB8MJdeleted per query
(DELETED)
Jan-25-2021
13:10:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
ddeleted per query
Jan-25-2021
00:49:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1:
Reissued:
OpenedDM: Please
consider to mark
this page as No
leaving comment at
field #4 as sampling
done on V3. Thank
you.
Jan-22-2021
09:56:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 1:
Answere
dserum obtained at
Visit 3 on
14JAN2021 is also
for Visit 101 which
occurred on
19JAN2021
Jan-21-2021
15:39:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
OpenedDMW6942621;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Jan-21-2021
08:01:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
BRB8MJInitial Entry
5.b
Date Location User Value Reason
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132277
Page 156 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Jan-25-2021 13:10:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMMRdeleted per query
(DELETED)
Jan-21-2021 08:02:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMMRInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-26-2021
05:58:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Malerato Moloi
(pfe moloim)Query 1:
ClosedResponse satisfies
query
Jan-25-2021
13:10:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
BNWM
MRdeleted per query
(DELETED)
Jan-22-2021
09:57:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 1:
Answere
dserum obtained at
Visit 3 on
14JAN2021 is also
for Visit 101 which
occurred on
19JAN2021
Jan-21-2021
15:39:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
OpenedDMW6942619;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Jan-21-2021
08:02:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
BNWM
MRInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132278
Page 157 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
5.c
Date Location User Value Reason
Jan-25-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMMSdeleted per query
(DELETED)
Jan-21-2021 08:02:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMMSInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132279
Page 158 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
5.c Sample ID
Date Location User Value Reason
Jan-26-2021
04:27:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1:
ClosedResponse satisfies
query
Jan-25-2021
13:10:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
BNWM
MSdeleted per query
(DELETED)
Jan-25-2021
13:10:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
ddeleted per query
Jan-25-2021
04:11:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Malerato Moloi
(pfe moloim)Query 1:
Reissued:
OpenedDM: Please
consider marking
Sample Collected?
as No and provide
reason on field 4
then remove the
barcode as the site
has confirmed that it
was done on visit 3.
Jan-22-2021
09:57:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query 1:
Answere
dserum obtained at
Visit 3 on
14JAN2021 is also
for Visit 101 which
occurred on
19JAN2021
Jan-21-2021
15:39:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1:
OpenedDMW6942620;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132280
Page 159 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Jan-21-2021
08:02:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Data Ent
ry:
BNWM
MSInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132281
Page 160 of 172
***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: 10071315 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
Jan-19-2021 11:16:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 11:16:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 11:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 11:16:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-19-2021 11:16:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021 11:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BRB8N6Initial Entry
5.a Sample ID
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132282
Page 161 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Jan-19-2021 11:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BRB8N6Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132283
Page 162 of 172
***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: 10071315 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
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/19/2021 10:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132284
Page 163 of 172
***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: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
7. Route:
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-19-2021 11:16:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132285
Page 164 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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-09-2021 13:08:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/9/2021Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132286
Page 165 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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-09-2021 13:08:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-09-2021 13:08:24
(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-09-2021 15:00:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-09-2021 13:08:24
(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-09-2021 13:08:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-09-2021 15:00:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BRB94VInitial Entry
5.a Sample ID
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132287
Page 166 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Feb-09-2021 15:00:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BRB94VInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132288
Page 167 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/9/2021 12:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132289
Page 168 of 172
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
7. Route:
Date Location User Value Reason
Feb-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-09-2021 13:29:27
(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-09-2021 13:29:27
(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-09-2021 13:29:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132290
Page 169 of 172
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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
Mar-10-2021 09:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Mar/9/2021Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132291
Page 170 of 172
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-10-2021 09:27:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-10-2021 09:28:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-10-2021 09:28:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Contact:
Mar/9/2021Transcription Error
Mar-10-2021 09:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Contact
10/Mar/2021 is not
equal to the Date of
Visit 09/Mar/2021
within same visit.
Please review and
update as
appropriate.
Mar-10-2021 09:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Contact:
Mar/10/2021Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132292
Page 171 of 172
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071315 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
Mar-10-2021 09:32:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Mar/9/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021 09:32:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-10-2021 09:32:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132293
Page 172 of 172
***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: 10071315 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
Jan-14-2021 14:06:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-13-2020 14:09:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-13-2020 12:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-14-2021 14:06:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/14/2021Initial Entry
Oct-13-2020 14:09:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Oct-13-2020 12:27:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
090177e196d89036\Final\Final On: 22-Apr-2021 02:14 (GMT)
FDA-CBER-2021-5683-0132294