Document text
Page 1 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131452
Page 2 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug/27/2020
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131453
Page 3 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071280]
2.Birth Date: /1982
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0131454
Page 4 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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 Aug/27/2020
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131455
Page 5 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131456
Page 6 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131457
Page 7 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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:[Kidney stones]
Start Date: Nov/UNK/2019
Ongoing: NO
End Date:
Aug/4/2020
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lithotripsy]
Start Date: Nov/UNK/2019
Ongoing: NO
End Date:
Nov/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pyeloplasty]
Start Date: Aug/4/2020
Ongoing: NO
End Date:
Aug/4/2020
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1997
Ongoing: YES
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131458
Page 8 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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:[Seasonal allergy]
Start Date: UNK/UNK/1990
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic to cats]
Start Date: UNK/UNK/1990
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dust allergy]
Start Date: UNK/UNK/1990
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleeve gastrectomy]
Start Date: May/UNK/2019
Ongoing: NO
End Date:
May/UNK/2019
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Overweight]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
Jun/UNK/2020
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131459
Page 9 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [75.4]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [24.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131460
Page 10 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131461
Page 11 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [68493]
3.Randomization Group: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131462
Page 12 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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:
Aug/27/2020
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 [BP75JJ]
5.bSample ID [BP75JK]
5.cSample ID [BP75JL]
5.dSample ID [BPG0F5]
5.eSample ID [BPG0F6]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131463
Page 13 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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:
Aug/27/2020
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 [BP75J8]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131464
Page 14 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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: Aug/27/2020 10:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131465
Page 15 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131466
Page 16 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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 Sep/23/2020
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131467
Page 17 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131468
Page 18 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131469
Page 19 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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:
Sep/23/2020
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 [BPYTSJ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131470
Page 20 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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?YES
Date of First Delay:
Sep/17/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 09:15
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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131471
Page 21 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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/21/2020
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131472
Page 22 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[samples are in convalescent visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131473
Page 23 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10071280 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 Sep/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131474
Page 24 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/17/2020
2.Date of First Symptom Started: Sep/12/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/17/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [headache]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131475
FDA-CBER-2021-5683-0131476
Page 26 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131477
Page 27 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10071280 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_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[subject came in for visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131478
Page 28 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: 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: 10071280 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:
Sep/17/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYTR6]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131479
Page 29 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131480
FDA-CBER-2021-5683-0131481
Page 31 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131482
Page 32 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131483
FDA-CBER-2021-5683-0131484
Page 34 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131485
Page 35 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131486
Page 36 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131487
Page 37 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131488
Page 38 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131489
FDA-CBER-2021-5683-0131490
Page 40 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131491
FDA-CBER-2021-5683-0131492
Page 42 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131493
FDA-CBER-2021-5683-0131494
Page 44 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: OXYGENATION PARAMETERS
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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131495
Page 45 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131496
Page 46 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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.Start Date: //
6.Ongoing?
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131497
FDA-CBER-2021-5683-0131498
Page 48 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131499
Page 49 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/21/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 10071280 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/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131500
Page 50 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/21/2020Form: 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: 10071280 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/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYV5B]
5.bSample ID [BMRTLB]
5.cSample ID [BMRTLC]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131501
Page 51 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131502
Page 52 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131503
Page 53 of 212
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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 :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131504
Page 54 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131505
Page 55 of 212
***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: 10071280 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:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131506
Page 56 of 212
***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: 10071280 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 [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131507
Page 57 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Muscle Soreness in arm of injecti
on Jan/28/2021 2
0:00 NO
End Date Time:
Jan/30/2021 08:00
Repeating
Pages
2.ADVERSE EV
ENT 2 bilateral deep cervical swollen ly
mph nodes Feb/18/2021 0
8:00 NO
End Date Time:
Feb/25/2021 UNK:UNK
Repeating
Pages
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131508
Page 58 of 212
***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: 10071280 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)[Muscle Soreness in arm of injection]
4.Start Date Time: Jan/28/2021 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/30/2021 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? 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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131509
Page 59 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131510
Page 60 of 212
***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: 10071280 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[bilateral deep cervical swollen lymph nodes]
4.Start Date Time: Feb/18/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/25/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131511
Page 61 of 212
***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: 10071280 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?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131512
Page 62 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131513
Page 63 of 212
***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: 10071280 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[ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131514
Page 64 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131515
Page 65 of 212
***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: 10071280 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: //
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131516
Page 66 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131517
Page 67 of 212
***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: 10071280 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?
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131518
FDA-CBER-2021-5683-0131519
Page 69 of 212
***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: 10071280 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?
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131520
FDA-CBER-2021-5683-0131521
Page 71 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131522
Page 72 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131523
Page 73 of 212
***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: 10071280 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:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131524
Page 74 of 212
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131525
Page 75 of 212
***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: 10071280 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?
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131526
Page 76 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131527
Page 77 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131528
Page 78 of 212
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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/24/2020
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131529
Page 79 of 212
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131530
Page 80 of 212
***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: 10071280 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/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131531
Page 81 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131532
Page 82 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131533
Page 83 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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 Jan/28/2021
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131534
Page 84 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan/28/2021
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131535
Page 85 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131536
Page 86 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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 :Jan/28/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131537
Page 87 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/28/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131538
Page 88 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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:
Jan/28/2021
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 [BRB8ZX]
5.bSample ID [BNWMW6]
5.cSample ID [BNWMW8]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131539
Page 89 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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:
Jan/28/2021
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 [BRB900]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131540
Page 90 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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: Jan/28/2021 13:14
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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131541
Page 91 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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/17/2021
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131542
Page 92 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/17/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131543
Page 93 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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/17/2021
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 [BR0ZR5]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131544
Page 94 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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/17/2021 13:35
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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131545
Page 95 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131546
Page 96 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131547
Page 97 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131548
Page 98 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131549
Page 99 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131550
Page 100 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131551
Page 101 of 212
***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: 10071280 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: [ ]
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131552
Page 102 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131553
Page 103 of 212
***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: 10071280 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
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131554
Page 104 of 212
***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: 10071280 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-08-2021 22:50:53 (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.
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131555
Page 105 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-27-2020 10:31:03 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131556
Page 106 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormSep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131557
Page 107 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131558
Page 108 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131559
Page 109 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131560
Page 110 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131561
Page 111 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131562
Page 112 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131563
Page 113 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
7Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131564
Page 114 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
8Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131565
Page 115 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
9Sep-17-2020 10:55:49 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Done
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131566
Page 116 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-28-2021 13:51:28 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131567
Page 117 of 212
***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: 10071280 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-08-2021 22:50:53 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Haley Muth N/A Feb-17-2021 13:40:01 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Jan-29-2021 22:57:13 (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 Jan-28-2021 13:50:35 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Oct-28-2020 18:26:06 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131568
Page 118 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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.
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131569
Page 119 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 10:00:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131570
Page 120 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:00:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131571
Page 121 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:00:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071280Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 10:00:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1982Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 10:00:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 10:00:58
(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
Aug-27-2020 10:00:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0131572
Page 122 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:01:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Aug/27/2020Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131573
Page 123 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:31:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 10:31:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 10:31:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131574
Page 124 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 10:34:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Kidney stones
Start Date: Nov/UNK/201
9
Ongoing: NO
End Date:
Aug/4/2020Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:34:28
(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
Aug-27-2020 10:34:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Kidney stonesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 10:34:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 10:34:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date:
Aug/4/2020Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131575
Page 125 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b
Date Location User Value Reason
Aug-27-2020 10:35:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Lithotripsy
Start Date: Nov/UNK/2019
Ongoing: NO
End Date:
Nov/UNK/20
19Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:35:08
(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
Aug-27-2020 10:35:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
LithotripsyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 10:35:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Nov/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 10:35:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date:
Nov/UNK/2019Initial Entry
1.c
Date Location User Value Reason
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131576
Page 126 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-27-2020 10:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:Pyeloplasty
Start Date: Aug/4/2020
Ongoing: NO
End Date:
Aug/4/202
0Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:35:43
(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
Aug-27-2020 10:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
PyeloplastyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-27-2020 10:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Aug/4/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020 10:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date:
Aug/4/2020Initial Entry
1.d
Date Location User Value Reason
Aug-27-2020 10:36:01
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131577
Page 127 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada) Medical History Ter
m:Asthma
Start Date: UNK/UNK/19
97
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:36:01
(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
Aug-27-2020 10:36:01
(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
Aug-27-2020 10:36:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/1997Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-27-2020 10:36:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-27-2020 10:36:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Seasonal allerg
y
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131578
Page 128 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:36:32
(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
Aug-27-2020 10:36:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Seasonal allergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-27-2020 10:36:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-27-2020 10:36:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-27-2020 10:36:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Allergic to cats
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131579
Page 129 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:36:48
(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
Aug-27-2020 10:36:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Allergic to catsInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-27-2020 10:36:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/1990Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-27-2020 10:36:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-27-2020 10:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Dust allergy
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131580
Page 130 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.g Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:37:08
(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
Aug-27-2020 10:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Dust allergyInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-27-2020 10:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/1990Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-27-2020 10:37:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-27-2020 10:37:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:Sleeve gastrecto
my
Start Date: May/UNK/2019
Ongoing: NO
End Date:
May/UNK/20
19Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131581
Page 131 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.h Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:37:37
(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
Aug-27-2020 10:37:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sleeve gastrectomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-27-2020 10:37:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
May/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-27-2020 10:37:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date:
May/UNK/2019Initial Entry
1.i
Date Location User Value Reason
Aug-27-2020 10:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Ter
m:Overweight
Start Date: UNK/UNK/199
6
Ongoing: NO
End Date:
Jun/UNK/20
20Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131582
Page 132 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.i Line/MH Number:
Date Location User Value Reason
Aug-27-2020 10:38:06
(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
Aug-27-2020 10:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
OverweightInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-27-2020 10:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UNK/UNK/1996Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-27-2020 10:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date:
Jun/UNK/2020Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131583
Page 133 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
75.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 10:32:37
(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
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.9Initial Entry
7.a
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131584
Page 134 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 10:32:37
(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
Aug-27-2020 10:32:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131585
Page 135 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131586
Page 136 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131587
Page 137 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:33:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020
04:05:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Cavin van Schalkwyk
(pfe.vanscc01)Query 1: Close
dResponse
satisfies query
Aug-28-2020
12:22:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Aug-28-2020
12:22:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Data Entry:
68493Transcription
Error
Aug-28-2020
09:01:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 1: Open
edAs per Impala,
Randomization
Number is 68493
. Please review
and update as
appropriate.
"[newtod07
SDQ=1861]"
Aug-27-2020
10:33:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Data Entry:
48493Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131588
Page 138 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:31:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 10:31:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 14:03:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 10:31:34
(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.
Aug-27-2020 10:31:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 14:03:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75JJInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 14:03:41 ACV0PFEINFP6000 Jesse Data Entry: Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131589
Page 139 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)LePage
(pfe.jlepage)BP75JJ
5.b
Date Location User Value Reason
Aug-27-2020 14:03:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75JKInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 14:03:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BP75JKInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 14:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75JLInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 14:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BP75JLInitial Entry
5.d
Date Location User Value Reason
Aug-27-2020 14:08:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0F5Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 14:08:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0F5Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131590
Page 140 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.e
Date Location User Value Reason
Aug-27-2020 14:08:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0F6Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 14:08:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0F6Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131591
Page 141 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 10:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 14:00:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 10:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-27-2020 10:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 14:00:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75J8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 14:00:21 ACV0PFEINFP6000 Jesse Data Entry: Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131592
Page 142 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)LePage
(pfe.jlepage)BP75J8
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131593
Page 143 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Aug/27/2020 10:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131594
Page 144 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-27-2020 10:48:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131595
Page 145 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Aug-27-2020 10:48:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131596
Page 146 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Sep-23-2020 08:56:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sep/23/2020Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131597
Page 147 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 08:56:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020 08:56:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 08:56:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-23-2020 08:56:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020 08:56:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 08:56:38
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131598
Page 148 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada)
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131599
Page 149 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131600
Page 150 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-23-2020 08:56:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131601
Page 151 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Sep-23-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 11:38:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-23-2020 08:56:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 11:38:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTSJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 11:38:03 ACV0PFEINFP6000 Jesse Data Entry: Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131602
Page 152 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)LePage
(pfe.jlepage)BPYTSJ
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131603
Page 153 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of First Delay:
Sep/17/2020
Reason(s) for Temporary Delay of Va
ccination
FEVER OR ACUTE ILLNESSInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sep/23/2020 09:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131604
Page 154 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-23-2020 10:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131605
Page 155 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-24-2020
03:52:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Nikita Singh
(pfe.singhn98)Query
1: Clo
sedResponse satisfies query
Oct-23-2020
09:23:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query
1: Ans
weredSubject had a combined Visit 3
and Convalescent Visit
Oct-23-2020
02:16:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW5123368;The Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L
is the same as the other Date
of Visit at Visit COVID_A1.
Please review for duplication
and update as appropriate.
Oct-21-2020
10:08:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry
:
Oct/21
/2020Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131606
Page 156 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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-21-2020 10:10:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 10:10:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 10:10:38
(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
Oct-21-2020 10:10:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
samples are in convalescent visitInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131607
Page 157 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10071280 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
Sep-17-2020 10:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-17-2020 10:44:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Sep-17-2020 10:44:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Sep-17-2020 10:44:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sep/17/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-08-2020 05:47:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sharat Nair
(pfe nairs51)Query 1: Closed Response satisfies
query
Oct-07-2020 07:34:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered subject was referring
to past of symptoms
because that is how
the question is asked
on the covid illness
diary. "Did you have
any symptoms in the
past week?"
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131608
Page 158 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-29-2020 04:00:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sonali shah
(pfe.shahs132)Query 1: Opened As per Illness ediary
records, subject
reported "Yes" for the
question "Have you
experienced any of the
following?”for the
COVID-19 symptoms
or diagnosis on
18SEP2020. But there
is COVID Illness visit
reported in the
database for
17SEP2020. Please
clarify
Sep-17-2020 10:44:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131609
Page 159 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sep/17/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Sep/12/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-04-2020 01:37:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Response satisfies
query
Nov-03-2020 15:18:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered 18sep2020 is the day
subject responded to
the question on the
diary which as in the
past week did you
experience any
symptoms
Nov-03-2020 01:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Reissued:Opened RQ1: Response states
'not a new event; this
was the 17sep2020
event'. Please confirm
if Illness ediary entry
on 18SEP2020 was
deemed erroneous.
Please update or
clarify.
Nov-02-2020 10:32:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered reviewed this is not a
new event; this was
the 17sep2020 event
Oct-31-2020 08:49:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sonali shah
(pfe.shahs132)Query 1: Opened Illness eDiary: Per
COVID illness diary
18SEP2020 was
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131610
Page 160 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
reported as Yes and
symptoms ongoing is
reported with date as
17SEP2020. Please
review and confirm if
18SEP2020 reported
is new event in
comment.
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
Date of Last Symptom Resolved:
Sep/17/2020Initial Entry
4.a
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131611
Page 161 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.b Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131612
Page 162 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.d Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Sep-17-2020 10:46:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:Initial Entry
4.e Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEW OR INCREASED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:46:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131613
Page 163 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom P
resent:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEW OR INCREASED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
4.h
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131614
Page 164 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Sep-17-2020 10:45:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131615
Page 165 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020 10:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Symptoms - Other: headacheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Sep-17-2020 10:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
headacheInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131616
Page 166 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
7. Test Result:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131617
Page 167 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Sep-17-2020 10:55:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not DoneInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131618
Page 168 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - 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: 10071280 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
Sep-17-2020 10:55:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 10:55:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 12:55:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020 12:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Sample
Collected?" is No, but
Barcodes are present
on the page.
Sep-17-2020 10:55:21
(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
Sep-17-2020 10:55:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
subject came in for visitInitial Entry
5.a
Date Location User Value Reason
Sep-17-2020 12:55:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID:Changed Information
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131619
Page 169 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020 12:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTR6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 12:55:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020 12:55:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry: Changed Information
Sep-17-2020 12:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 7
characters in length.
Please review and
correct as appropriate.
Sep-17-2020 12:54:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTR6Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131620
Page 170 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: 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: 10071280 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
Sep-17-2020 10:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 10:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 12:56:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 10:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-17-2020 10:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 12:56:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTR6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 12:56:16 ACV0PFEINFP6000 Jesse Data Entry: Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131621
Page 171 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)LePage
(pfe.jlepage)BPYTR6
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131622
Page 172 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Type of Practitioner: EMERGENC
Y ROOM
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131623
Page 173 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Type of Practition
er:PRIMARY CAR
E PHYSICIAN
Occurrence of Vis
its or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Type of Practitioner: URGENT C
ARE
Occurrence of Visits or
Contacts:NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131624
Page 174 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Type of Practition
er:TELEPHONE CO
NSULTATION
Occurrence of Vis
its or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Cont
acts:NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131625
Page 175 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-17-2020 10:50:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Sep-17-2020 10:51:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131626
Page 176 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/17/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Sep-17-2020 15:13:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Sep-17-2020 15:13:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Sep-17-2020 15:13:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131627
Page 177 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/21/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-24-2020
07:28:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query
1: Clo
sedResponse satisfies query
Oct-23-2020
09:23:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jesse LePage
(pfe.jlepage)Query
1: Ans
weredSubject had a combined Visit 3
and Convalescent Visit
Oct-23-2020
02:16:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW5123367;The Date of
Visit at Visit COVID_A1 is the
same as the other Date of Visit
at Visit
V3_MONTH1_POSTVAX2_L.
Please review for duplication
and update as appropriate.
Oct-21-2020
10:09:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry
:
Oct/2
1/202
0Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-21-2020 10:09:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
COVID_A1Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131628
Page 178 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/21/2020Form: 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: 10071280 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-21-2020 10:09:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 10:09:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 10:58:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 10:09:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-21-2020 10:09:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 10:58:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYV5BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 10:58:35 ACV0PFEINFP6000 Jesse Data Entry: Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131629
Page 179 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/21/2020Form: 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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)LePage
(pfe.jlepage)BPYV5B
5.b
Date Location User Value Reason
Oct-21-2020 10:59:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTLBInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 10:59:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTLBInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 10:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTLCInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 10:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTLCInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131630
Page 180 of 212
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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-21-2020 10:09:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 10:09:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 10:09:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131631
Page 181 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Form Created
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131632
Page 182 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Form Created
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131633
Page 183 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Muscle Soreness in arm of injectionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Jan/28/2021 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Jan/30/2021 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131634
Page 184 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-17-2021 17:42:16
(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
Feb-17-2021 17:42:16
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131635
Page 185 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-17-2021 17:42:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131636
Page 186 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
bilateral deep cervical swollen lymph n
odesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Feb/18/2021 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Feb/25/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131637
Page 187 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021 01:29:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Mar-05-2021 11:22:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Mar-05-2021 11:22:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RELATEDInitial Entry
Mar-05-2021 00:10:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM: The response
for "Is this event
related to study
treatment" is missing.
Kindly review and
update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131638
Page 188 of 212
***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: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021 15:19:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131639
Page 189 of 212
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:50:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Dec/24/2020Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131640
Page 190 of 212
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:51:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Participant is willing to return for Vacc
ination 3
Participant is:
eligible per local/national recomme
ndations and confirmed to have rec
eived only placebo at Vaccination 1
/2Transcription Error
Jan-28-2021 13:50:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Participant is willing to return for Vacc
ination 3Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131641
Page 191 of 212
***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: 10071280 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
Jan-28-2021 13:50:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-28-2021 13:50:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131642
Page 192 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:51:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Jan/28/2021Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131643
Page 193 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:51:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/28/2021Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131644
Page 194 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:51:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Jan/28/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-28-2021 13:51:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-28-2021 13:51:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131645
Page 195 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Jan/28/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131646
Page 196 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-28-2021 13:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131647
Page 197 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:52:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 13:52:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 15:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 13:52:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-28-2021 13:52:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-28-2021 15:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BRB8ZXInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-28-2021 15:26:03 ACV0PFEINFP6000 Jesse Data Entry: Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131648
Page 198 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)LePage
(pfe.jlepage)BRB8ZX
5.b
Date Location User Value Reason
Jan-28-2021 15:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMW6Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-28-2021 15:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BNWMW6Initial Entry
5.c
Date Location User Value Reason
Jan-28-2021 15:26:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BNWMW8Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-28-2021 15:26:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BNWMW8Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131649
Page 199 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:52:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 13:52:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 15:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 13:52:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-28-2021 13:52:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-28-2021 15:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BRB900Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-28-2021 15:24:05 ACV0PFEINFP6000 Jesse Data Entry: Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131650
Page 200 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)LePage
(pfe.jlepage)BRB900
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131651
Page 201 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Jan/28/2021 13:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131652
Page 202 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-28-2021 13:52:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131653
Page 203 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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-17-2021 13:40:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Feb/17/2021Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131654
Page 204 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Feb/17/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131655
Page 205 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-17-2021 13:40:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
NEGATIVEInitial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131656
Page 206 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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-17-2021 13:41:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 13:41:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021 10:17:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021 08:10:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-17-2021 13:41:07
(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-17-2021 13:41:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley Muth
(pfe hmuth)Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021 10:17:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
Sample ID: BR0ZR5Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131657
Page 207 of 212
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Feb-18-2021 10:17:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe mmesseder)Data Entry:
BR0ZR5Initial Entry
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131658
Page 208 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 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-17-2021 14:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-17-2021 14:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-17-2021 14:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-17-2021 14:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
Feb/17/2021 13:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-17-2021 14:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-17-2021 14:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Haley
Muth
(pfe.hmuth)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4027\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131659
Page 209 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071280 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Feb-17-2021 14:46:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value R
…[truncated]