125742 S1 M5 CRF c4591001 1007 10071276

Document text

Page 1 of 187
***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: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131265
Page 2 of 187
***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: 10071276 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/26/2020
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131266
Page 3 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071276]
2.Birth Date: /1977
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0131267
Page 4 of 187
***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: 10071276 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/26/2020
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131268
Page 5 of 187
***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: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131269
Page 6 of 187
***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: 10071276 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/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131270
Page 7 of 187
***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: 10071276 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:[Asthma]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vasectomy]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal allergy]
Start Date: UNK/UNK/1987
Ongoing: YES
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131271
Page 8 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [91.4]
3.Unit: kg
4.Height: [187.0]
5.Unit: cm
6.Body Mass Index: [26.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131272
Page 9 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [68489]
3.Randomization Group: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131273
Page 10 of 187
***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: 10071276 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/26/2020
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 [BP75HL]
5.bSample ID [BP75HM]
5.cSample ID [BP75HN]
5.dSample ID [BPG0DV]
5.eSample ID [BPG0DW]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131274
Page 11 of 187
***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: 10071276 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/26/2020
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 [BP75H2]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131275
Page 12 of 187
***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: 10071276 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/26/2020 15:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131276
Page 13 of 187
***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: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131277
Page 14 of 187
***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: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131278
Page 15 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131279
Page 16 of 187
***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: 10071276 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 [BPYTRY]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131280
Page 17 of 187
***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: 10071276 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: Sep/17/2020 14:33
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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131281
Page 18 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131282
Page 19 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYV2P]
5.bSample ID [BMRTHG]
5.cSample ID [BMRTHH]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131283
Page 20 of 187
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131284
Page 21 of 187
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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 [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131285
Page 22 of 187
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131286
Page 23 of 187
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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 [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131287
Page 24 of 187
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131288
Page 25 of 187
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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 [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131289
Page 26 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131290
Page 27 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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: Oct/7/2020
2.Date of First Symptom Started: Oct/5/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/10/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131291
Page 28 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131292
Page 29 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/10/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131293
Page 30 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/10/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA certified lab; PCR test]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131294
Page 31 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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 unable]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131295
Page 32 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject unable]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131296
Page 33 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131297
FDA-CBER-2021-5683-0131298
Page 35 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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?
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131299
Page 36 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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?YES
Respiratory Illness Diagnosis:
[seasonal allergies]
Date of Diagnosis:
Oct/8/2020
3.Toxicity Grade: 1
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131300
FDA-CBER-2021-5683-0131301
Page 38 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131302
Page 39 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131303
Page 40 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131304
Page 41 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131305
Page 42 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131306
FDA-CBER-2021-5683-0131307
Page 44 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131308
FDA-CBER-2021-5683-0131309
Page 46 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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 % [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131310
FDA-CBER-2021-5683-0131311
Page 48 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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): [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131312
Page 49 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131313
Page 50 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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?
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131314
FDA-CBER-2021-5683-0131315
Page 52 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131316
Page 53 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131317
Page 54 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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 [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131318
Page 55 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/25/2020Form: 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: 10071276 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/25/2020
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131319
Page 56 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/25/2020Form: UNPLANNED VISIT
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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131320
Page 57 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/25/2020Form: CONTACT OUTCOME - UNPLANNED
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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/25/2020
Contact Outcome:
VISIT NOT ARRANGED, UNABLE TO ATTEND
3.Comments: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131321
Page 58 of 187
***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: 10071276 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/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131322
Page 59 of 187
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/30/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: PROTOCOL DEVIATION
4.Specify Status: [Receipt of non-study COVID vaccine prior to study end]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131323
Page 60 of 187
***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: 10071276 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:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131324
Page 61 of 187
***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: 10071276 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 [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131325
Page 62 of 187
***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: 10071276 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  leukocytosis  Sep/24/2020 UNK
:UNK NO
End Date Time:
Oct/19/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  thrombocytosis  Sep/24/2020 UNK
:UNK NO
End Date Time:
Oct/26/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EV
ENT 3  chronic myelogenous l
eukemia Sep/24/2020 UNK
:UNK YES  Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131326
Page 63 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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)[leukocytosis]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/19/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Chronic myelogenous leukemia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131327
Page 64 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131328
Page 65 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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)[thrombocytosis]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Chronic myelogenous leukemia]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131329
Page 66 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131330
Page 67 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chronic myelogenous leukemia]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131331
Page 68 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Genetic change in stem cells]
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020373397]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131332
Page 69 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131333
Page 70 of 187
***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: 10071276 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[ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131334
Page 71 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of MedicationStart Da
teForm Instanc
e
 1.1  VACCINATION
S NO  SARS-CoV-2 vaccina
tion Pfizer Dec/30/2
020 Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131335
Page 72 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[SARS-CoV-2 vaccination Pfizer]
5.Date: Dec/30/2020
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131336
Page 73 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Define
d IdentifierCategory for MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationDose Desc
riptionForm Instan
ce
 1.1  CONCOMITANT IMMUNOSU
PPRESSIVE THERAPY NO  Dasatinib  100  Repeating
Pages
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131337
Page 74 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Dasatinib]
5.Dose: [100]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Oct/6/2020
10.Ongoing? YES
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131338
FDA-CBER-2021-5683-0131339
Page 76 of 187
***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: 10071276 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?
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131340
FDA-CBER-2021-5683-0131341
Page 78 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131342
Page 79 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131343
Page 80 of 187
***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: 10071276 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:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131344
Page 81 of 187
***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: 10071276 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?
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131345
Page 82 of 187
***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: 10071276 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: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131346
Page 83 of 187
***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: 10071276 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: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131347
Page 84 of 187
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131348
Page 85 of 187
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131349
Page 86 of 187
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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 [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131350
Page 87 of 187
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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 [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131351
Page 88 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131352
Page 89 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131353
Page 90 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: OTHER
If other, specify:
[Subject plans to receive non-study COVID vaccine]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131354
Page 91 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131355
Page 92 of 187
***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: 10071276 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: [ ]
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131356
Page 93 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/30/2020
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131357
Page 94 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131358
Page 95 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131359
Page 96 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-26-2020 15:17:38 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131360
Page 97 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Laura Pace  N/A Mar-11-2021 15:49:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck  Approved Mar-08-2021 22:48:48 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Laura Pace  N/A Feb-21-2021 11:05:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck  Approved Feb-07-2021 22:56:53 (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.
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131361
Page 98 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Laura Pace  N/A Jan-30-2021 09:38:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck  Approved Oct-30-2020 12:00:10 (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 Oct-29-2020 11:46:11 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck  Approved Oct-28-2020 18:25:42 (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 Oct-28-2020 16:56:36 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131362
Page 99 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Robert Frenck  Approved Oct-26-2020 17:54:33 (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 Oct-26-2020 10:46:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck  Approved Oct-22-2020 08:35:55 (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.
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131363
Page 100 of 187
***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: 10071276 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-26-2020 15:16:51
(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-26-2020 15:16:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131364
Page 101 of 187
***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: 10071276 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-26-2020 15:16:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/26/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131365
Page 102 of 187
***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: 10071276 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-26-2020 15:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10071276Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 15:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1977Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 15:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 15:17:14
(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-26-2020 15:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0131366
Page 103 of 187
***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: 10071276 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-26-2020 15:17:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131367
Page 104 of 187
***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: 10071276 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-26-2020 15:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 15:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 15:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131368
Page 105 of 187
***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: 10071276 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-26-2020 15:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Asthma
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020 15:22:42
(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-26-2020 15:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
AsthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020 15:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020 15:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131369
Page 106 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-26-2020 15:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Vasectomy
Start Date: UNK/UNK/201
6
Ongoing: NO
End Date:
UNK/UNK/
2016Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020 15:24:00
(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-26-2020 15:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
VasectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020 15:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020 15:24:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131370
Page 107 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c
Date Location User Value Reason
Oct-16-2020 20:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:Seasonal aller
gy
Start Date: UNK/UNK/1
987
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-16-2020 20:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 20:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Seasonal allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-16-2020 20:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1987Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-16-2020 20:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131371
Page 108 of 187
***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: 10071276 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-26-2020 15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
91.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
187.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 15:19:13
(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-26-2020 15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.1Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131372
Page 109 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.a
Date Location User Value Reason
Aug-26-2020 15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 15:19:13
(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-26-2020 15:19:13
(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-26-2020 15:19:13
(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-26-2020 15:19:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131373
Page 110 of 187
***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: 10071276 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-26-2020 15:21:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 15:21:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
68489Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131374
Page 111 of 187
***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: 10071276 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-26-2020 15:18:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 15:18:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 16:02:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 15:18:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 15:18:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 16:02:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75HLInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131375
Page 112 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 16:02:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BP75HLInitial Entry
5.b
Date Location User Value Reason
Aug-26-2020 16:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75HMInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020 16:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BP75HMInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020 16:03:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75HNInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020 16:03:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BP75HNInitial Entry
5.d
Date Location User Value Reason
Aug-26-2020 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0DVInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131376
Page 113 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Sample ID
Date Location User Value Reason
Aug-26-2020 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0DVInitial Entry
5.e
Date Location User Value Reason
Aug-26-2020 16:26:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0DWInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020 16:26:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0DWInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131377
Page 114 of 187
***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: 10071276 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-26-2020 15:18:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 15:18:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 15:42:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 15:18:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 15:18:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 15:42:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75H2Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131378
Page 115 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 15:42:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BP75H2Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131379
Page 116 of 187
***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: 10071276 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-26-2020 15:56:02
(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-26-2020 15:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 15:56:02
(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-26-2020 15:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/26/2020 15:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 15:56:02
(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-26-2020 15:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131380
Page 117 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7. Route:
Date Location User Value Reason
Aug-26-2020 15:56:02
(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-26-2020 15:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-26-2020 15:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131381
Page 118 of 187
***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: 10071276 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-26-2020 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131382
Page 119 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 05:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Response satisfies
query
Oct-14-2020 15:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered subject had visit on
07oct2020
Oct-13-2020 09:24:50
(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
08OCT2020. But
there is no COVID
Illness visit reported
in the database.
Sep-17-2020 14:20:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
Sep/17/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131383
Page 120 of 187
***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: 10071276 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-17-2020 14:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 14:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 37.2
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 14:20:43
(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-17-2020 14:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
37.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 14:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131384
Page 121 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-17-2020 14:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131385
Page 122 of 187
***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: 10071276 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 14:21:05
(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 14:21:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 15:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 14:21:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-17-2020 14:21:05
(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 15:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTRYInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131386
Page 123 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 15:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTRYInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131387
Page 124 of 187
***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: 10071276 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-17-2020 15:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 15:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 15:11:25
(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-17-2020 15:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/17/2020 14:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 15:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020 15:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131388
Page 125 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7. Route:
Date Location User Value Reason
Sep-17-2020 15:11:25
(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-17-2020 15:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-17-2020 15:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131389
Page 126 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 15:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Oct/15/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131390
Page 127 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 15:26:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 15:26:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 15:26:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 15:26:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 15:26:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 15:26:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYV2PInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131391
Page 128 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 15:26:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPYV2PInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 15:26:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTHGInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 15:26:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTHGInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BMRTHHInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BMRTHHInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131392
Page 129 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 01:43:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Swapna
Varikuti
(pfe.variks)Query 1: Closed As per site
confirmation -
updated PD tracker
Oct-15-2020 08:31:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered correct neither nasal
swab was done
Oct-15-2020 07:13:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Swapna
Varikuti
(pfe.variks)Query 1: Opened PDQ : Details for
either Nasal Swab
Self or Nasal Swab
expected to be
completed. Please
check and update
else clarify.
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-14-2020 15:46:36
(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.
Oct-14-2020 15:46:36
(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.
Oct-14-2020 15:46:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
Oct/7/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131393
Page 130 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-14-2020 15:46:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131394
Page 131 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/7/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/5/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-15-2020 19:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-15-2020 19:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NO
Date of Last Symptom Resolved:
Oct/10/2020Transcription Error
Oct-15-2020 19:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Last Symptom
Resolved Date is
before the First
Symptom Start Date.
Please correct.
Oct-15-2020 19:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NO
Date of Last Symptom Resolved:
Sep/10/2020New Information
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131395
Page 132 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.a
Date Location User Value Reason
Oct-14-2020 15:51:42
(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
Oct-14-2020 15:51:42
(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
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131396
Page 133 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.b Symptoms:
Date Location User Value Reason
Oct-14-2020 15:51:42
(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
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BRE
ATH
Sympto
m Prese
nt:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131397
Page 134 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-14-2020 15:51:42
(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
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.f
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131398
Page 135 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW LOSS OF TASTE OR SMEL
LInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131399
Page 136 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.g Symptoms:
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-14-2020 15:51:42
(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
Oct-14-2020 15:51:42
(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
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131400
Page 137 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.i Symptoms:
Date Location User Value Reason
Oct-14-2020 15:51:42
(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
Oct-14-2020 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131401
Page 138 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131402
Page 139 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/10/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
OTHERInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131403
Page 140 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7. Test Result:
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-15-2020 19:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
CLIA certified lab; PCR testInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131404
Page 141 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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-14-2020 15:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 15:53:41
(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
Oct-14-2020 15:53:41
(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-14-2020 15:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
subject unableInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131405
Page 142 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: 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: 10071276 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-14-2020 15:53:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 15:53:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 15:53:57
(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-14-2020 15:53:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
subject unableInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131406
Page 143 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 15:47:01
(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
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Type of Practitione
r:EMERGENC
Y ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131407
Page 144 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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
Oct-14-2020 15:47:01
(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
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Type of Practitio
ner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 15:47:01
(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
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131408
Page 145 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 15:47:01
(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
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Type of Practiti
oner:TELEPHONE C
ONSULTATIO
N
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131409
Page 146 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 15:47:01
(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
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-14-2020 15:47:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 15:47:01
(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
Oct-14-2020 15:47:01
(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
Oct-14-2020 15:47:01
(UTC-05:00) EasternACV0PFEINFP6000  Laura
PaceData Entry:
NOInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131410
Page 147 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.lpace)
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131411
Page 148 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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
Oct-14-2020 15:54:14
(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
Mar-11-2021 15:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YES
Respiratory Illness Diagnosis:
seasonal allergies
Date of Diagnosis:
Oct/8/2020New Information
Oct-14-2020 15:54:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020 15:54:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131412
Page 149 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/25/2020Form: 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-04-2020 19:56:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Xiaoxia
Liu
(pfe.xiaoxl)Query 1: Closed Response satisfies
query
Oct-01-2020 16:10:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered subject had an SAE
Sep-28-2020 20:12:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Xiaoxia
Liu
(pfe.xiaoxl)Query 1: Opened ClinQuery: Please
can you confirm why
subject was called
for UNPL visit?
Subject is not part of
reactogenicity subset
of patients. If this
pertains to an AE
please update AE log
else clarify. Thanks
Sep-25-2020 16:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
Sep/25/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131413
Page 150 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/25/2020Form: UNPLANNED VISIT - 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Assessments
Date Location User Value Reason
Sep-25-2020 16:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 16:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Sep-25-2020 16:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131414
Page 151 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/25/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-25-2020 16:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-25-2020 16:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YES
Date of Contact:
Sep/25/2020
Contact Outcome:
VISIT NOT ARRANGED, UN
ABLE TO ATTENDInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131415
Page 152 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 15:27:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 15:27:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 15:27:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131416
Page 153 of 187
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - 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: 10071276 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-30-2021 09:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Dec/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-30-2021 09:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-22-2021 07:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley
Wyper
(pfe.wyperh)Query 1: Closed Response satisfies
query
Feb-21-2021 11:05:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-21-2021 11:05:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
PROTOCOL DEVIATIONChanged
Information
Feb-15-2021 05:53:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley
Wyper
(pfe.wyperh)Query 1: Reissued:Opened CLINQUERY:
Please update status
selection in field to
match to
PROTOCOL
DEVIATION (will
link to non-study
covid-19 vaccine
receipt prior to study
end)
Feb-14-2021 18:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered protocol deviation
completed
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131417
Page 154 of 187
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Feb-08-2021 02:20:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Sathenapalli
Suguna
Srujan
(pfe.srujas)Query 1: Opened CLINQUERY: If
non-study covid-19
vaccine was received
prior to study end,
please capture as
PROTOCOL
DEVIATION status
Feb-05-2021 06:03:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley
Wyper
(pfe.wyperh)Query 1: Candidate CLINQUERY: If
non-study covid-19
vaccine was received
prior to study end,
please capture as
PROTOCOL
DEVIATION status
Jan-30-2021 09:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NO LONGER MEETS ELIGIBI
LITY CRITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-21-2021 11:05:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Receipt of non-study COVID vacci
ne prior to study endChanged
Information
Jan-30-2021 09:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Exclusion 12; received a COVID-1
9 vaccine outside of the study.Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131418
Page 155 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Sep-25-2020 16:35:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131419
Page 156 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Sep-25-2020 16:38:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131420
Page 157 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131421
Page 158 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020 16:35:56
(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
Nov-05-2020 14:46:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Nov-04-2020 14:38:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered this was already
done; see all AEs
Nov-04-2020 11:33:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 1: Opened CLINICAL Please
clarify if a more
specific diagnosis
of CML has be
reached; if so
please update and
report the specific
diagnosis
Nov-04-2020 11:30:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 1: Candidate CLINICAL Please
clarify if a more
specific diagnosis
of CML has be
reached; if so
please update and
report the specific
diagnosis
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131422
Page 159 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
leukocytosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020 10:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Oct/19/2020 UNK:UNKNew Information
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 14:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
3Changed Information
Oct-27-2020 17:46:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Juleen
Gayed
(pfe.gayedj)Query 1: Closed Clin: Posted in error
Oct-27-2020 17:44:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Juleen
Gayed
(pfe.gayedj)Query 1: Opened Clin: Please clarify
how this AE is
life-threatening
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131423
Page 160 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 05:29:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-15-2020 19:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE
leukocytosis:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Oct-15-2020 19:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NOChanged
Information
Sep-28-2020 03:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Deleted Query can be
addressed internally
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
leukocytosis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
NOInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131424
Page 161 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
YES
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020 09:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
Chronic myelogenous leuke
miaNew Information
Sep-25-2020 16:35:56 ACV0PFEINFP6000  Laura Data Entry: Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131425
Page 162 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)Pace
(pfe.lpace)NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
Probable lymphoproliferative
disorder
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020 16:35:56
(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
Sep-25-2020 16:35:56
(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
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020 10:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-26-2020 10:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-26-2020 10:46:59
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE leukocytosis:
Response to "What
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131426
Page 163 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020 16:35:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-16-2020 05:29:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry: downgraded to non
serious in both
database
Sep-28-2020 05:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020373397Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131427
Page 164 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-25-2020 16:38:52
(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
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
thrombocytosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-28-2020 16:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date Time:
Oct/26/2020 UNK:UNKNew Information
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131428
Page 165 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 12:05:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed
Hassan
(pfe hassaa38)Query 2: Closed Response satisfies query
Oct-29-2020 11:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
Oct-29-2020 11:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
3Changed Information
Oct-29-2020 09:37:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed
Hassan
(pfe hassaa38)Query 2: Opened ClinQuery:thrombocytosis:
this is listed as a grade 4
AE but is also listed as a
not serious. Please review
and update as appropriate.
Thanks
Oct-27-2020 17:45:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed
(pfe.gayedj)Query 1: Closed Clin: Posted in error
Oct-27-2020 17:45:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed
(pfe.gayedj)Query 1: Opened Clin: Please clarify how
this AE is life-threatening
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-23-2020 11:12:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed updated per SAE
report
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131429
Page 166 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-23-2020 11:07:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical - SAE report
states
"Thrombocytosis
does still need to be
reported as an SAE.
It was inadvertently
removed from the
report sent to Pfizer
on 09Oct2020." If
statement is correct,
please return this
event to 'Serious =
yes'.
Oct-16-2020 05:28:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-15-2020 19:56:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE
thrombocytosis:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Oct-15-2020 19:56:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NOChanged Information
Sep-28-2020 03:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Deleted Query can be
addressed internally
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
thrombocytosis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131430
Page 167 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
YES
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-12-2020 09:43:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHERChanged
Information
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131431
Page 168 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
If Other, specify:
Chronic myelogenous leuke
mia
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
Probable lymphoproliferative
disorderInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-25-2020 16:38:52
(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
Sep-25-2020 16:38:52
(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
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 16:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131432
Page 169 of 187
***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, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-28-2020 16:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-28-2020 16:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
thrombocytosis:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-25-2020 16:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-16-2020 05:28:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry: downgraded to non
serious in both
database
Sep-28-2020 05:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020373397Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131433
Page 170 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
chronic myelogenous leukemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-01-2021 14:00:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Christian
Mayfield
(pfe.mayfic01)Query 1: Closed Response satisfies
query
Feb-01-2021 12:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered Ae will not have an
end date
Jan-30-2021 09:38:58
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131434
Page 171 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) completed and this
Adverse Event is
still ongoing. Please
review and update
as appropriate.
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 13:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Oct-29-2020 11:29:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 2: Answered will include in
follow up SAE form
Oct-28-2020 23:44:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical - querying
to have SAE report
include any COVID
test performed at
Hosp. Orig response
was "there was a
covid test done and
result was negative;
testing was not
performed due to the
SAE", which is
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131435
Page 172 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
unclear.
Oct-27-2020 16:34:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 2: Answered can you please
clarify what question
you are referring to.
I do not understand
what you are asking
Oct-26-2020 16:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical The
question only refers
to (non-study) Covid
tests in ER/Hospital.
If NO hospital Covid
test performed is
known, please
submit this on
follow-up SAE form
as pertinent
information for this
trial.
Oct-26-2020 09:57:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 2: Answered there was a covid
test done and result
was negative; testing
was not performed
due to the SAE
Oct-23-2020 11:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020373397] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-16-2020 05:28:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE chronic
myelogenous
leukemia: Response
to "Is the adverse
event serious?" is
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131436
Page 173 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
YES
Other medically important seri
ous event
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
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131437
Page 174 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Genetic change in stem cellsInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-15-2020 19:59:41
(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
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021
02:52:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed SDB update
Feb-11-2021
13:04:16
(UTC-05:00) EasternACV0PFEINFP6000  Gladys Noi
(pfe noig)Query 1: Reissued:Cand
idatepending SDB update
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131438
Page 175 of 187
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
Feb-10-2021
11:51:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered updated SAE report
Feb-10-2021
00:31:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2020373397,outcome
was updated to
RECOVERING/RESOLVING on
AE CRF while reported as Not
Recovered/Not Resolved in Safety
database. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-01-2021
12:51:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
RECOVERING/RESOL
VINGChanged Information
Oct-15-2020
19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-15-2020 19:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-16-2020 05:28:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020373397Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131439
Page 176 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Jan-31-2021 20:23:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131440
Page 177 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - 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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-31-2021 20:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Jan-31-2021 20:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-31-2021 20:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Jan-31-2021 20:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
SARS-CoV-2 vaccination PfizerInitial Entry
5. Date:
Date Location User Value Reason
Jan-31-2021 20:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Dec/30/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131441
Page 178 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Form Created
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131442
Page 179 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
CONCOMITANT IMMUNOSUPP
RESSIVE THERAPYInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
DasatinibInitial Entry
5. Dose:
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
100Initial Entry
6. Dose Unit:
Date Location User Value Reason
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131443
Page 180 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/6/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Oct-16-2020 20:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131444
Page 181 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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-30-2021 09:39:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Dec/23/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131445
Page 182 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 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-30-2021 09:40:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Participant is NOT willing to return
for Vaccination 3 OR otherwise not
eligibleInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131446
Page 183 of 187
***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: 10071276 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-30-2021 09:39:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Dec/30/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-10-2021
02:51:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Amol Deshmukh
(pfe.deshma24)Query
2: Clo
sedClosed per site
confirmation.
Mar-08-2021
21:23:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query
2: An
swere
dcorrect as entered
Mar-08-2021
05:21:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Amol Deshmukh
(pfe.deshma24)Query
2: Rei
ssued:
Opene
dIVRS Re-query 1:
Thank you for
response. Please
confirm primary reason
for unblinding recorded
'Other' is correct. Else,
update as appropriate.
Mar-04-2021
21:49:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dChanged Information
Mar-04-2021
21:49:06
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data
Entry
:
OTH
ERChanged Information
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131447
Page 184 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Canada) If ot
her,
spec
ify:
Su
bje
ct
pla
ns
to r
ece
ive
no
n-s
tud
y
C
O
VI
D
va
cci
ne
Mar-04-2021
05:06:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Mar-04-2021
02:55:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Amol Deshmukh
(pfe.deshma24)Query
2: Op
enedIVRS Reconciliation:
Other is selected as the
primary reason for
unblinding but
matching blind break is
not captured in IRT.
Please correct primary
reason in Inform or
confirm as correct”.
Mar-03-2021
23:00:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Gajanan Deshmukh
(pfe.deshmg08)Query
1: Rei
ssued:
Opene
dDM : Primary Reason
for Unblinding is
recorded as OTHER.
However, Other,
specify is missing.
Please review and
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131448
Page 185 of 187
***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: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
update. Else,clarify.
Mar-03-2021
14:33:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dChanged Information
Mar-03-2021
14:33:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data
Entry
:
OTH
ERChanged Information
Feb-22-2021
08:57:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7349520;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-30-2021
09:39:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131449
Page 186 of 187
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-21-2021 11:05:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged
Information
Jan-30-2021 09:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-15-2020 15:27:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-26-2020 15:21:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-26-2020 15:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-21-2021 11:05:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/30/2020Changed
Information
Jan-30-2021 09:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/30/2020Initial Entry
Oct-15-2020 15:27:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Aug-26-2020 15:21:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
Aug-26-2020 15:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131450
Page 187 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071276 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 16:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Click Here to EnableInitial Entry
090177e196ae4021\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131451