Document text
Page 1 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132295
Page 2 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/15/2020
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132296
Page 3 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071347]
2.Birth Date: /1952
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:
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132297
Page 4 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132298
Page 5 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132299
Page 6 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132300
Page 7 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary artery disease]
Start Date: UNK/UNK/2006
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cardiac surgery]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1980
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132301
Page 8 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[COPD]
Start Date: UNK/UNK/2000
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fundoplication]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/1989
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Reflux esophagitis]
Start Date: UNK/UNK/1989
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hepatitis B]
Start Date: UNK/UNK/1970
Ongoing: NO
End Date:
UNK/UNK/1973
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132302
Page 9 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hepatitis C]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/2000
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post-traumatic stress disorder]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[drug allergy Penicillin]
Start Date: UNK/UNK/1958
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to food - shellfish]
Start Date: UNK/UNK/1952
Ongoing: YES
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132303
Page 10 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[drug allergy sulfa]
Start Date: UNK/UNK/1958
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iodine allergy]
Start Date: UNK/UNK/2006
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Enlarged prostate (benign)]
Start Date: Apr/25/2011
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tobacco use disorder, continuous use]
Start Date: UNK/UNK/1975
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132304
Page 11 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Nov/25/2011
Ongoing: YES
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132305
Page 12 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132306
Page 13 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
2.Weight: [92.0]
3.Unit: kg
4.Height: [180.0]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132307
Page 14 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/15/2020
2.Randomization Number: [269840]
3.Randomization Group: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132308
Page 15 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYV2N]
5.bSample ID [BMRTHD]
5.cSample ID [BMRTHF]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132309
Page 16 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYV2K]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132310
Page 17 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 14:40
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
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132311
Page 18 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132312
Page 19 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132313
Page 20 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132314
Page 21 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[subject not vaccinated due to SAE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132315
Page 22 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132316
Page 23 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132317
Page 24 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/3/2020
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 [BP90JY]
5.bSample ID [BMRWD1]
5.cSample ID [BMRWD4]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132318
Page 25 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132319
Page 26 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132320
Page 27 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132321
Page 28 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132322
Page 29 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132323
Page 30 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132324
Page 31 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132325
Page 32 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132326
Page 33 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132327
Page 34 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132328
Page 35 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Identif
ierAdverse Eve
ntStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 atrial fibrillati
on Oct/25/2020 11
:30 NO
End Date Time:
Oct/26/2020 UNK:UNK
Repeating
Pages
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132329
Page 36 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[atrial fibrillation]
4.Start Date Time: Oct/25/2020 11:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132330
Page 37 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
[history of coronary artery disease]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020415465]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132331
Page 38 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132332
Page 39 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132333
Page 40 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132334
Page 41 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132335
Page 42 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132336
Page 43 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132337
FDA-CBER-2021-5683-0132338
Page 45 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132339
FDA-CBER-2021-5683-0132340
Page 47 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132341
Page 48 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132342
Page 49 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132343
Page 50 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132344
Page 51 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132345
Page 52 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132346
Page 53 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132347
Page 54 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132348
Page 55 of 181
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132349
Page 56 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132350
Page 57 of 181
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132351
Page 58 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132352
Page 59 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132353
Page 60 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132354
Page 61 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132355
Page 62 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132356
Page 63 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/1/2021
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132357
Page 64 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132358
Page 65 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132359
Page 66 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
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 [BRB91B]
5.bSample ID [BNWMWV]
5.cSample ID [BNWMWW]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132360
Page 67 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
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 [BRB918]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132361
Page 68 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/1/2021 13:18
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
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132362
Page 69 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132363
Page 70 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
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 [BR0ZXS]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132364
Page 71 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/23/2021 10:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132365
Page 72 of 181
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132366
Page 73 of 181
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132367
Page 74 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132368
Page 75 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132369
Page 76 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132370
Page 77 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132371
Page 78 of 181
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132372
Page 79 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/5/2020
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132373
Page 80 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132374
Page 81 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Frenck Approved Mar-09-2021 21:31:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132375
Page 82 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-15-2020 14:28:15 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132376
Page 83 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormNov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132377
Page 84 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132378
Page 85 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132379
Page 86 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132380
Page 87 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132381
Page 88 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132382
Page 89 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132383
Page 90 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
7Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132384
Page 91 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
8Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132385
Page 92 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
9Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132386
Page 93 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
10Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132387
Page 94 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
11Nov-09-2020 07:16:00 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)subject not vaccinated due to SAE
Not Done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132388
Page 95 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-01-2021 14:55:13 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132389
Page 96 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Frenck Approved Mar-09-2021 21:31:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Laura Pace N/A Feb-23-2021 10:39:41 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Feb-07-2021 23:03:48 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Laura Pace N/A Feb-01-2021 11:42:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132390
Page 97 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Robert Frenck Approved Jan-23-2021 17:42:32 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132391
Page 98 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-15-2020 14:27:28
(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-15-2020 14:27:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132392
Page 99 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-15-2020 14:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/15/2020Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132393
Page 100 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-15-2020 14:27:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071347Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-15-2020 14:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-15-2020 14:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-15-2020 14:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-15-2020 14:27:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0132394
Page 101 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 14:28:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/15/2020Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132395
Page 102 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-15-2020 14:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 14:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 14:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132396
Page 103 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Oct-29-2020 14:59:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Coronary arter
y disease
Start Date: UNK/UNK/20
06
Ongoing: YESChanged
Information
Oct-20-2020 12:37:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:Coronary artery
disease
Start Date: UNK/UNK/200
6
Ongoing: NO
End Date:
UNK/UNK/
2006Changed
Information
Oct-15-2020 18:37:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Chest pain
Start Date: UNK/UNK/20
06
Ongoing: NO
End Date:
UNK/UNK
/2006Initial Entry
1.a Line/MH Number:
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132397
Page 104 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-15-2020 18:37:39
(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-30-2020 12:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe hassaa38)Query 2: Closed Response satisfies
query
Oct-30-2020 11:43:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered it was updated
Oct-30-2020 02:51:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sathenapalli
Suguna
Srujan
(pfe.srujas)Query 2: Reissued:Opened Thanks for the
response, form has
been unfreeze,
please update as
per below query
Oct-29-2020 13:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe hassaa38)Query 2: Reissued:Candidate DM: Please
unfreeze so site can
update this data
point
Oct-29-2020 12:28:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered yes once it is
unfrozen
Oct-29-2020 12:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe hassaa38)Query 2: Opened ClinQUERY:
Please update stop
date per query on
AE log.
Oct-21-2020 20:44:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Closed Response satisfies
query
Oct-20-2020 12:37:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-20-2020 12:37:00
(UTC-05:00) EasternACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Coronary artery diseaseChanged
Information
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132398
Page 105 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
Oct-18-2020 20:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Opened ClinQuery: Chest
pain: Please can
you confirm if a
diagnosis is
known? If so
please update the
verbatim term.
Thanks
Oct-15-2020 18:37:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Chest painInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-15-2020 18:37:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2006Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-29-2020 14:59:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESChanged
Information
Oct-15-2020 18:37:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.b
Date Location User Value Reason
Oct-15-2020 18:38:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Cardiac surger
yInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132399
Page 106 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date: UNK/UNK/20
06
Ongoing: NO
End Date:
UNK/UNK/
2006
1.b Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:38:30
(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-15-2020 18:38:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Cardiac surgeryInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-15-2020 18:38:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2006Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-15-2020 18:38:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.c
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132400
Page 107 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 18:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Hypertension
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:38:54
(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-15-2020 18:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-15-2020 18:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-15-2020 18:38:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132401
Page 108 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 18:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Asthma
Start Date: UNK/UNK/19
90
Ongoing: NO
End Date:
UNK/UNK/
2000Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132402
Page 109 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:39:35
(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-15-2020 18:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
AsthmaInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-15-2020 18:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1990Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-15-2020 18:39:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.e
Date Location User Value Reason
Oct-15-2020 18:39:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:COPD
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132403
Page 110 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:39:54
(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-15-2020 18:39:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COPDInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-15-2020 18:39:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2000Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-15-2020 18:39:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-15-2020 18:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Fundoplication
Start Date: UNK/UNK/19
89Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132404
Page 111 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: NO
End Date:
UNK/UNK/
1989
1.f Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:40:31
(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-15-2020 18:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FundoplicationInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-15-2020 18:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1989Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-15-2020 18:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1989Initial Entry
1.g
Date Location User Value Reason
Oct-15-2020 18:41:06
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 7Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132405
Page 112 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) r:
Medical History
Term:Reflux esoph
agitis
Start Date: UNK/UNK/1
989
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:41:06
(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-15-2020 18:41:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Reflux esophagitisInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-15-2020 18:41:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1989Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-15-2020 18:41:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-15-2020 18:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 8Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132406
Page 113 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
er:
Medical History
Term:Hepatitis B
Start Date: UNK/UNK/19
70
Ongoing: NO
End Date:
UNK/UNK/
1973
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132407
Page 114 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.h Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:41:41
(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-15-2020 18:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Hepatitis BInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-15-2020 18:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1970Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-15-2020 18:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/1973Initial Entry
1.i
Date Location User Value Reason
Oct-15-2020 18:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Hepatitis C
Start Date: UNK/UNK/19
99Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132408
Page 115 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: NO
End Date:
UNK/UNK/
2000
1.i Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:42:32
(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-15-2020 18:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Hepatitis CInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-15-2020 18:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1999Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-15-2020 18:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.j
Date Location User Value Reason
Oct-15-2020 18:43:31
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 10Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132409
Page 116 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) mber:
Medical Hist
ory Term:Post-traumatic str
ess disorder
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/20
16
1.j Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:43:31
(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-15-2020 18:43:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Post-traumatic stress disorderInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-15-2020 18:43:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2016Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-15-2020 18:43:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.k
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132410
Page 117 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-15-2020 18:45:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical Histor
y Term:drug allergy Pe
nicillin
Start Date: UNK/UNK/19
58
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:45:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 18:45:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
drug allergy PenicillinInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-15-2020 18:45:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1958Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-15-2020 18:45:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132411
Page 118 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 18:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:12
Medical Histo
ry Term:Allergy to food
- shellfish
Start Date: UNK/UNK/195
2
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 18:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Allergy to food - shellfishInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-15-2020 18:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1952Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-15-2020 18:45:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132412
Page 119 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 18:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:drug allergy
sulfa
Start Date: UNK/UNK/1
958
Ongoing: YESInitial Entry
1.m Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 18:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
drug allergy sulfaInitial Entry
1.m Start Date:
Date Location User Value Reason
Oct-15-2020 18:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1958Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-15-2020 18:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132413
Page 120 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 18:47:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:14
Medical History
Term:Iodine allerg
y
Start Date: UNK/UNK/2
006
Ongoing: YESInitial Entry
1.n Line/MH Number:
Date Location User Value Reason
Oct-15-2020 18:47:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 18:47:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Iodine allergyInitial Entry
1.n Start Date:
Date Location User Value Reason
Oct-15-2020 18:47:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2006Initial Entry
1.n Ongoing:
Date Location User Value Reason
Oct-15-2020 18:47:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132414
Page 121 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-29-2020 15:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:15
Medical Histo
ry Term:Enlarged prostat
e (benign)
Start Date: Apr/25/2011
Ongoing: YESInitial Entry
1.o Line/MH Number:
Date Location User Value Reason
Oct-29-2020 15:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 15:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Enlarged prostate (benign)Initial Entry
1.o Start Date:
Date Location User Value Reason
Oct-29-2020 15:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Apr/25/2011Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-29-2020 15:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Oct-29-2020 15:04:27
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132415
Page 122 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) Line/MH N
umber:16
Medical His
tory Term:Tobacco use disord
er, continuous use
Start Date: UNK/UNK/1975
Ongoing: YES
1.p Line/MH Number:
Date Location User Value Reason
Oct-29-2020 15:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 15:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Tobacco use disorder, continuous
useInitial Entry
1.p Start Date:
Date Location User Value Reason
Oct-29-2020 15:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1975Initial Entry
1.p Ongoing:
Date Location User Value Reason
Oct-29-2020 15:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Nov-02-2020 13:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Numbe 17New Information
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132416
Page 123 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
r:
Medical History
Term:Depression
Start Date: UNK/UNK/
2016
Ongoing: YES
Oct-29-2020 15:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Ter
m:Depressio
n
Start Date:
Ongoing: YESInitial Entry
1.q Line/MH Number:
Date Location User Value Reason
Oct-29-2020 15:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 15:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
DepressionInitial Entry
1.q Start Date:
Date Location User Value Reason
Nov-03-2020 03:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
Nov-02-2020 13:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132417
Page 124 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.q Start Date:
Date Location User Value Reason
Nov-02-2020 13:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/2016New Information
Nov-01-2020 23:28:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: Please
complete this item.
Thank you.
1.q Ongoing:
Date Location User Value Reason
Oct-29-2020 15:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Oct-29-2020 15:06:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:18
Medical Histor
y Term:Hypercholester
olemia
Start Date: Nov/25/2011
Ongoing: YESInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132418
Page 125 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.r Line/MH Number:
Date Location User Value Reason
Oct-29-2020 15:06:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 15:06:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HypercholesterolemiaInitial Entry
1.r Start Date:
Date Location User Value Reason
Oct-29-2020 15:06:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/25/2011Initial Entry
1.r Ongoing:
Date Location User Value Reason
Oct-29-2020 15:06:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132419
Page 126 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-15-2020 14:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132420
Page 127 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-15-2020 14:48:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
92.0Transcription Error
Oct-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
53.3Initial Entry
3. Unit:
Date Location User Value Reason
Oct-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-15-2020 14:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
180.0Transcription Error
Oct-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
162.5Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132421
Page 128 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 14:46:31
(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-15-2020 14:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.4Transcription Error
Oct-15-2020 14:48:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.8Transcription Error
Oct-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20.2Initial Entry
7.a
Date Location User Value Reason
Oct-15-2020 14:49:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier
::1
Temperature: 37.0
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYTranscription Error
Oct-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier
::1
Temperature: 36.3
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132422
Page 129 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 14:46:31
(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-15-2020 14:49:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
37.0Transcription Error
Oct-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-15-2020 14:46:31
(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-15-2020 14:46:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132423
Page 130 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-15-2020 14:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-15-2020 14:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
269840Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132424
Page 131 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 14:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 14:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 15:24:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 14:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 14:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 15:24:50
(UTC-05:00) EasternACV0PFEINFP6000 Jesse
LePageData Entry:
Sample ID: BPYV2NInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132425
Page 132 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.jlepage)
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 15:24:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYV2NInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 15:25:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTHDInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 15:25:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTHDInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 15:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTHFInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 15:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTHFInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132426
Page 133 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 14:49:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 14:49:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 15:12:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 14:49:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 14:49:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 15:12:20
(UTC-05:00) EasternACV0PFEINFP6000 Jesse
LePageData Entry:
Sample ID: BPYV2KInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132427
Page 134 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.jlepage)
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 15:12:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYV2KInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132428
Page 135 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/15/2020 14:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132429
Page 136 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020 15:33:08
(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-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-15-2020 15:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132430
Page 137 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-15-2020 15:33:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132431
Page 138 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020 01:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Nov-09-2020 07:16:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered uodated
Nov-09-2020 06:05:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: Kindly
consider to update
missing SWAB
PFE, VACIN TRT
forms or else
clarify. Thank
you.
Nov-05-2020 16:30:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/5/2020Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132432
Page 139 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Nov-05-2020 16:31:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/5/2020Initial Entry
2.a
Date Location User Value Reason
Nov-05-2020 16:31:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:
:1
Temperature: 36.9
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-05-2020 16:31:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-05-2020 16:31:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-05-2020 16:31:14
(UTC-05:00) EasternACV0PFEINFP6000 Laura
PaceData Entry:
CInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132433
Page 140 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.lpace)
2.a Temperature Location:
Date Location User Value Reason
Nov-05-2020 16:31:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132434
Page 141 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-09-2020 07:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-09-2020 07:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-09-2020 07:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-09-2020 07:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
subject not vaccinated due to SA
EInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132435
Page 142 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132436
Page 143 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-09-2020 07:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132437
Page 144 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-03-2020 13:29:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/3/2020Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132438
Page 145 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 13:29:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 13:29:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-03-2020 15:50:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-03-2020 13:29:26
(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-03-2020 13:29:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
Dec-03-2020 15:50:56
(UTC-05:00) EasternACV0PFEINFP6000 Morgan
MessederData Entry:
Sample ID: BP90JYInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132439
Page 146 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe mmesseder)
5.a Sample ID
Date Location User Value Reason
Dec-03-2020 15:50:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BP90JYInitial Entry
5.b
Date Location User Value Reason
Dec-03-2020 15:51:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BMRWD1Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-03-2020 15:51:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BMRWD1Initial Entry
5.c
Date Location User Value Reason
Dec-03-2020 15:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BMRWD4Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-03-2020 15:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BMRWD4Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132440
Page 147 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132441
Page 148 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 16:33:42
(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
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
atrial fibrillationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/25/2020 11:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020 16:51:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Oct/26/2020 UNK:UNKNew Information
Oct-26-2020 16:33:42
(UTC-05:00) EasternACV0PFEINFP6000 Laura
PaceData Entry:
YESInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132442
Page 149 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.lpace)
6. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 09:27:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed SAE report
submitted with Neg
Covid test result
10/25/20
Oct-29-2020 09:08:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered information
included in follow
up SAE form
Oct-28-2020 05:26:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 00:07:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical – Thank
you. If NO hospital
Covid test was
performed is
known, please
submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
Oct-27-2020 16:48:50
(UTC-05:00) EasternACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered covid testing was
not done
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132443
Page 150 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
Oct-27-2020 15:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE
form
[#2020415465] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE atrial
fibrillation:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result
in persistent or significant di
sability/incapacity?Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132444
Page 151 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious event
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
Oct-26-2020 16:33:42
(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
Oct-29-2020
15:35:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ahmed Hassan
(pfe.hassaa38)Query
2: Clos
edResponse
satisfies query
Oct-29-2020
14:59:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Query
2: Ans
weredupdated
Oct-29-2020
12:08:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ahmed Hassan
(pfe.hassaa38)Query
2: Reis
sued:O
penedquery issued on
the medhx to
unfreeze. please
update as
appropriate &
leave with you
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132445
Page 152 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
until the page is
available to be
updated. thanks
Oct-29-2020
11:41:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Query
2: Ans
weredCAD is
ongoing, will
update med
history
Oct-29-2020
09:34:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ahmed Hassan
(pfe.hassaa38)Query
2: Ope
nedClinQuery:atrial
fibrillation:
Question 9
states this is
related to a
previous history
of CAD,
however, in the
medhx, CAD
has an end date
of 2006. If this
was ongoing at
baseline, please
update as
appropriate.
Thanks
Oct-28-2020
03:35:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Gajanan Deshmukh
(pfe.deshmg08)Query
1: Clos
edResponse
satisfies query
Oct-27-2020
17:13:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Query
1: Ans
weredcan you please
clairfy
Oct-27-2020
06:22:22
(UTC-05:00)
Eastern TimeACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
1: Ope
nedPlease review
"If not related
to study
treatment other"
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132446
Page 153 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US &
Canada)field, the
following text
was indicated in
the comment
field [coronary
artery disease].
Any symptoms,
AEs or other
key data should
be collected on
the appropriate
page. Please
review and
update as
necessary.
"[lv04
SDQ=21183]"
Oct-26-2020
16:33:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s),
this e
vent i
s due
to:
OT
HE
R
If
Ot
her
, s
pe
cif
y:Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132447
Page 154 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
h
is
t
o
r
y
o
f
c
o
r
o
n
a
r
y
a
rt
e
r
y
d
is
e
a
s
e
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-02-2020
16:20:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 3: Closed Response satisfies query
Dec-02-2020
14:56:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 3: Answer
edupdated the SAE report
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132448
Page 155 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Dec-02-2020
06:47:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann Piojo
(pfe.quitor)Query 3: Opened SAE
RECON:AER#2020415465,action
taken was updated to DRUG
WITHDRAWN in AE CRF while
NOT APPLICABLE in Safety
database.Please confirm correct
action taken. If safety update is
required, please submit a follow
up form
Dec-01-2020
10:20:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 2: Closed Response satisfies query
Dec-01-2020
08:28:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edChanged Information
Dec-01-2020
08:28:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
DRUG WITHDR
AWNChanged Information
Nov-30-2020
02:41:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Swetha
Thangellapally
(pfe.thangs22)Query 2: Opened CLINQUERY: Please review if
this AE, Atrial Fibrillation,
contributed to decision to end
treatment. If so, field to be
updated to DRUG
WITHDRAWN. If unrelated,
please leave as is.
Nov-27-2020
07:14:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 2: Candida
teCLINQUERY: Please review if
this AE, Atrial Fibrillation,
contributed to decision to end
treatment. If so, field to be
updated to DRUG
WITHDRAWN. If unrelated,
please leave as is.
Oct-27-2020
22:29:01
(UTC-05:00)ACV0PFEINFP6000 Ricell Ann Piojo
(pfe.quitor)Query 1: Closed Response satisfies query
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132449
Page 156 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
Oct-27-2020
16:51:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edInitial Entry
Oct-27-2020
16:51:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOT APPLICAB
LEInitial Entry
Oct-27-2020
05:40:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann Piojo
(pfe.quitor)Query 1: Opened SAE RECON:AER#2020415465
,action taken was missing in AE
CRF while reported as NOT
APPLICABLE.Please confirm. If
safety update is required, please
submit a follow up form
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020 16:33:42
(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
Oct-26-2020 16:33:42
(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
Oct-28-2020
05:24:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed SDB outcome updated to
recovered/resolved
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132450
Page 157 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-27-2020
22:09:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reissued:O
penedSAE RECON 1:Outcome updated in
AE CRF as
RECOVERED/RESOLVED. Please
confirm if a follow up AEM form
was sent to update the outcome in
Safety database.
Oct-27-2020
16:51:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-27-2020
16:51:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE atrial fibrillation: Response
to "What was the outcome of this
adverse event?" is 3 but End
Date/Time is missing.
Oct-27-2020
16:51:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Oct-27-2020
16:51:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RECOVERED/RES
OLVEDChanged Information
Oct-27-2020
05:41:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2020415465,outcome
was reported as Unknown to Safety
DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-26-2020
16:33:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RECOVERING/RE
SOLVINGInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132451
Page 158 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020 16:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-28-2020 05:26:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020415465Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132452
Page 159 of 181
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-01-2020 10:20:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 3: Closed Response satisfies
query
Dec-01-2020 08:29:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Closed Close Auto Query
Dec-01-2020 08:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened Response to
"Status" is
ADVERSE EVENT
but "Specify Status"
is Provided.
Dec-01-2020 08:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed
Information
Dec-01-2020 08:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
ADVERSE EVENTChanged
Information
Nov-30-2020 01:47:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swetha
Thangellapally
(pfe.thangs22)Query 3: Opened CLINQUERY: Per
information on page
audit, the new onset
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132453
Page 160 of 181
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
AFib contributed to
the decision to end
treatment. If
correct, please link
the AE (AFib) to
this page: Status =
ADVERSE EVENT
and the AE entry to
indicate DRUG
WITHDRAWN
Nov-27-2020 07:11:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 3: Candidate CLINQUERY: Per
information on page
audit, the new onset
AFib contributed to
the decision to end
treatment. If
correct, please link
the AE (AFib) to
this page: Status =
ADVERSE EVENT
and the AE entry to
indicate DRUG
WITHDRAWN
Nov-13-2020 09:33:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe hassaa38)Query 2: Closed Response satisfies
query
Nov-13-2020 07:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 2: Answered updated
Nov-13-2020 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe hassaa38)Query 2: Opened Clin: EOT states the
primary reason for
discontinuation is
A-Fib. Please
update Q3 as
appropriate. Thanks
Nov-12-2020 18:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-12-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Status" is NO
LONGER MEETS
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132454
Page 161 of 181
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
ELIGIBILITY
CRITERIA but
"Specify Status" is
missing.
Nov-12-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO LONGER MEETS ELIGI
BILITY CRITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Dec-01-2020 08:29:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: Changed
Information
Nov-14-2020 10:40:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe.hassaa38)Query 1: Closed Response satisfies
query
Nov-14-2020 09:39:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-14-2020 09:39:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
subject did not meet inclusion
criteria #3Changed
Information
Nov-14-2020 07:56:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe.hassaa38)Query 1: Opened Clin: If subject is a
screen fail, or has
met an inclusion
criterion, please
update to state
subject DID NOT
MEET IC3.
Further, please
confirm if subject
will remain in
safety FU. Thanks
Nov-13-2020 07:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
meets inclusion criteria #3Changed
Information
Nov-12-2020 18:41:03
(UTC-05:00) EasternACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Participant has new onset AtriaInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132455
Page 162 of 181
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) l fib with current heart halter
monitor, unstable medical con
dition
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132456
Page 163 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-01-2021 11:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/23/2020Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132457
Page 164 of 181
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-01-2021 11:43:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132458
Page 165 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-01-2021 11:42:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-01-2021 11:42:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132459
Page 166 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-01-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/1/2021Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132460
Page 167 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-01-2021 14:55:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/1/2021Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132461
Page 168 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-01-2021 14:01:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Feb/1/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-01-2021 14:01:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-01-2021 14:01:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
COMPLETEDInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132462
Page 169 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-01-2021 14:05:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-01-2021 14:05:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-01-2021 14:05:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-01-2021 14:05:45
(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-01-2021 14:05:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
YES
Date of Collection:
Feb/1/2021Initial Entry
5.a
Date Location User Value Reason
Feb-01-2021 14:05:55 ACV0PFEINFP6000 Morgan Data Entry: Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132463
Page 170 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)Messeder
(pfe mmesseder)Sample ID: BRB91B
5.a Sample ID
Date Location User Value Reason
Feb-01-2021 14:05:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BRB91BInitial Entry
5.b
Date Location User Value Reason
Feb-01-2021 14:06:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BNWMWVInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-01-2021 14:06:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BNWMWVInitial Entry
5.c
Date Location User Value Reason
Feb-01-2021 14:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BNWMWWInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-01-2021 14:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BNWMWWInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132464
Page 171 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-01-2021 14:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-01-2021 14:02:08
(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-01-2021 14:02:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-01-2021 14:02:08
(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-01-2021 14:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
YES
Date of Collection:
Feb/1/2021Initial Entry
5.a
Date Location User Value Reason
Feb-01-2021 14:02:18 ACV0PFEINFP6000 Morgan Data Entry: Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132465
Page 172 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)Messeder
(pfe mmesseder)Sample ID: BRB918
5.a Sample ID
Date Location User Value Reason
Feb-01-2021 14:02:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BRB918Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132466
Page 173 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-01-2021 14:56:16
(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-01-2021 14:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-01-2021 14:56:16
(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-01-2021 14:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/1/2021 13:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-01-2021 14:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132467
Page 174 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-01-2021 14:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-01-2021 14:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-01-2021 14:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-01-2021 14:56:16
(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-01-2021 14:56:16
(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-01-2021 14:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132468
Page 175 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 10:39:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/23/2021Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132469
Page 176 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 10:39:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 10:39:53
(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-23-2021 10:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 10:39:53
(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-23-2021 10:39:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Feb/23/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021 10:50:03
(UTC-05:00) EasternACV0PFEINFP6000 Morgan
MessederData Entry:
Sample ID: BR0ZXSInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132470
Page 177 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe mmesseder)
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 10:50:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BR0ZXSInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132471
Page 178 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-23-2021 10:41:00
(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-23-2021 10:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-23-2021 10:41:00
(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-23-2021 10:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/23/2021 10:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-23-2021 10:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132472
Page 179 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-23-2021 10:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-23-2021 10:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-23-2021 10:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-23-2021 10:41:00
(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-23-2021 10:41:00
(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-23-2021 10:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132473
Page 180 of 181
***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: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-01-2020 08:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged
Information
Nov-12-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-15-2020 14:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-15-2020 14:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-01-2020 08:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/5/2020Changed
Information
Nov-12-2020 06:55:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/5/2020Initial Entry
Oct-15-2020 14:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Oct-15-2020 14:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132474
Page 181 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071347 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-22-2021 07:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Click Here to EnableInitial Entry
090177e196ae4028\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0132475