Document text
Page 1 of 201
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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
version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129965
Page 2 of 201
***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: 10071101 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
Jul/30/2020
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129966
Page 3 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071101]
2.Birth Date: /1963
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0129967
Page 4 of 201
***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: 10071101 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 Jul/30/2020
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129968
Page 5 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon
study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination,
and clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with
the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active suicidal
ideation/behavior/lab abnormality that may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129969
Page 6 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129970
Page 7 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective family
members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129971
Page 8 of 201
***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: 10071101 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
/DeathJul/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129972
Page 9 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10071101 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:[Obesity]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastric sleeve]
Start Date: Sep/UNK/2019
Ongoing: NO
End Date:
Sep/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep apnea]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129973
Page 10 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Supraventricular tachycardia]
Start Date: Oct/8/2019
Ongoing: Unknown Comments
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: Nov/UNK/2007
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2008
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129974
Page 11 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jul/30/2020
2.Weight: [129.6]
3.Unit: kg
4.Height: [167.5]
5.Unit: cm
6.Body Mass Index: [46.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129975
Page 12 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129976
Page 13 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/30/2020
2.Randomization Number: [220496]
3.Randomization Group: [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129977
Page 14 of 201
***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: 10071101 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:
Jul/30/2020
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 [BM8993]
5.bSample ID [BM8994]
5.cSample ID [BM8995]
5.dSample ID [BPFZVB]
5.eSample ID [BPFZVC]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129978
Page 15 of 201
***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: 10071101 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:
Jul/30/2020
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 [BM898V]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129979
Page 16 of 201
***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: 10071101 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: Jul/30/2020 13:11
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
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129980
Page 17 of 201
***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: 10071101 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 collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129981
Page 18 of 201
***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: 10071101 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/20/2020
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129982
Page 19 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129983
Page 20 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129984
Page 21 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129985
Page 22 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129986
Page 23 of 201
***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: 10071101 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/20/2020
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 [BP757Y]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129987
Page 24 of 201
***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: 10071101 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/20/2020 11:45
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
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129988
Page 25 of 201
***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: 10071101 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
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129989
Page 26 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129990
Page 27 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129991
Page 28 of 201
***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: 10071101 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:
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 [BPYTRJ]
5.bSample ID [BPG0HP]
5.cSample ID [BPG0HR]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129992
Page 29 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129993
Page 30 of 201
***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: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129994
Page 31 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129995
Page 32 of 201
***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: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129996
Page 33 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129997
Page 34 of 201
***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: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129998
Page 35 of 201
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129999
Page 36 of 201
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130000
Page 37 of 201
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130001
Page 38 of 201
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130002
Page 39 of 201
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130003
Page 40 of 201
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130004
Page 41 of 201
***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: 10071101 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:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130005
Page 42 of 201
***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: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130006
Page 43 of 201
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130007
Page 44 of 201
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130008
Page 45 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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 :Sep/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130009
Page 46 of 201
***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: 10071101 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 :Oct/21/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130010
Page 47 of 201
***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: 10071101 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:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130011
Page 48 of 201
***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: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130012
Page 49 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 Cardiac Arres
t Oct/18/2020 UNK:U
NK NO
End Date Time:
Oct/21/2020 UNK:UNK
Repeating
Pages
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130013
Page 50 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10071101 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)[Cardiac Arrest]
4.Start Date Time: Oct/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/21/2020 UNK:UNK
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?
YES
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
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:
[Heart attack. Occurred 2 months after last receipt of study agent]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130014
Page 51 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10071101 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?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020434734]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130015
Page 52 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categor
yMedication Err
orStart Da
teIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130016
Page 53 of 201
***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: 10071101 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[ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130017
Page 54 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130018
Page 55 of 201
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130019
Page 56 of 201
***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: 10071101 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
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130021
Page 58 of 201
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130022
Page 59 of 201
***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: 10071101 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?
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130023
Page 60 of 201
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130024
Page 61 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130025
Page 62 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130026
Page 63 of 201
***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: 10071101 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:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130027
Page 64 of 201
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130028
Page 65 of 201
***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: 10071101 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?
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130029
Page 66 of 201
***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: 10071101 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: [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130030
Page 67 of 201
***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: 10071101 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: [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130031
Page 68 of 201
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - 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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130032
Page 69 of 201
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130033
Page 70 of 201
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130034
Page 71 of 201
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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 [ ]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130035
Page 72 of 201
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130036
Page 73 of 201
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130037
Page 74 of 201
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130038
Page 75 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130039
Page 76 of 201
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Oct/21/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Cardiac Arrest]
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130040
Page 77 of 201
***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: 10071101 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 Oct/21/2020
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130041
Page 78 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130042
Page 79 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Frenck Approved Mar-10-2021 21:53:14 (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.
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130043
Page 80 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1.eNov-13-2020 07:17:42 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)end date unknown
Unknown
1.eNov-12-2020 12:49:22 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)end date unknown
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130044
Page 81 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130045
Page 82 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Jul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130046
Page 83 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Jul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130047
Page 84 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Jul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130048
Page 85 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Jul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130049
Page 86 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Jul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130050
Page 87 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aJul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130051
Page 88 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aJul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130052
Page 89 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aJul-30-2020 13:26:12 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130053
Page 90 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130054
Page 91 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Aug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130055
Page 92 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Aug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130056
Page 93 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130057
Page 94 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Aug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130058
Page 95 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Aug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130059
Page 96 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130060
Page 97 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130061
Page 98 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-20-2020 11:01:23 (UTC-05:00) Eastern Time
(US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130062
Page 99 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert Frenck Approved Mar-10-2021 21:53:14 (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 Mar-10-2021 13:28:50 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Mar-09-2021 21:17:08 (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.
Jennifer Wendell N/A Mar-09-2021 12:33:47 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Nov-16-2020 17:45:39 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130063
Page 100 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Laura Pace N/A Nov-16-2020 11:35:31 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Nov-13-2020 17:38:17 (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 Nov-10-2020 11:44:15 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Nov-09-2020 17:34:02 (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.
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130064
Page 101 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Laura Pace N/A Nov-09-2020 07:05:56 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Nov-06-2020 12:27:38 (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 Nov-05-2020 16:39:49 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Sep-17-2020 20:47:36 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Laura Pace N/A Sep-17-2020 12:08:34 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Aug-28-2020 16:11:26 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130065
Page 102 of 201
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130066
Page 103 of 201
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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
Jul-30-2020 13:00:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-30-2020 13:00:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130067
Page 104 of 201
***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: 10071101 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
Jul-30-2020 13:00:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/30/2020Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130068
Page 105 of 201
***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: 10071101 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
Jul-30-2020 12:59:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071101Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-30-2020 12:59:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1963Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-30-2020 13:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-30-2020 13:00:30
(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
Jul-30-2020 13:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130069
Page 106 of 201
***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: 10071101 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
Jul-30-2020 13:01:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130070
Page 107 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 y
ears, inclusive, or 18 and 85
years, inclusive, at randomiz
ation (dependent upon study
stage)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Male or female participants between t
he ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and 8
5 years, inclusive, at randomization (d
ependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130071
Page 108 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willing
and able to comply with all s
cheduled visits, vaccination
plan, laboratory tests, lifesty
le considerations, and other
study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN02A00Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130072
Page 109 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Inclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, va
ccination plan, laboratory tests, lifesty
le considerations, and other study proc
eduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histo
ry, physical examination, an
d clinical judgment of the in
vestigator to be eligible for i
nclusion in the studyInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130073
Page 110 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Healthy participants who are determin
ed by medical history, physical exami
nation, and clinical judgment of the in
vestigator to be eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Inclusi4Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130074
Page 111 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
on Nu
mber:
Criteri
on Desc
ription:Capable of giving personal s
igned informed consent, whi
ch includes compliance with
the requirements and restrict
ions listed in the ICD and in
this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN04A00
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130075
Page 112 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Inclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Capable of giving personal signed inf
ormed consent, which includes compli
ance with the requirements and restric
tions listed in the ICD and in this prot
ocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal i
deation/behavior/lab abnorm
ality that may increase the ri
sk of study participationInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130076
Page 113 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or activ
e suicidal ideation/behavior/lab abnor
mality that may increase the risk of st
udy participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura
PaceData Entry: Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130077
Page 114 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada) (pfe.lpace) Exclusio
n Numbe
r:2
Criterion
Descripti
on:Known infection with hum
an immunodeficiency viru
s (HIV), hepatitis C virus (
HCV), or hepatitis B virus
(HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Known infection with human immuno
deficiency virus (HIV), hepatitis C vir
us (HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX02A00Initial Entry
2.c
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130078
Page 115 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse re
action associated with a vac
cine and/or severe allergic r
eaction (eg, anaphylaxis) to
any component of the study
intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX03A00Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130079
Page 116 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.c Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
History of severe adverse reaction ass
ociated with a vaccine and/or severe a
llergic reaction (eg, anaphylaxis) to an
y component of the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preven
t COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130080
Page 117 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.d Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Receipt of medications intended to pr
event COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi
on Num
ber:8
Criterio
n Descr
iption:Immunocompromised indiv
iduals with known or suspe
cted immunodeficiency, as
determined by history and/o
r laboratory/physical exami
nation
Criterio
n met?:NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130081
Page 118 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Immunocompromised individuals wit
h known or suspected immunodeficie
ncy, as determined by history and/or l
aboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130082
Page 119 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Desc
ription:Bleeding diathesis or condit
ion associated with prolong
ed bleeding that would, in th
e opinion of the investigator
, contraindicate intramuscul
ar injection
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Bleeding diathesis or condition associ
ated with prolonged bleeding that wou
ld, in the opinion of the investigator, c
ontraindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX10A00Initial Entry
2.g
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130083
Page 120 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusion Num
ber:11
Criterion Descri
ption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Women who are pregnant or breastfee
dingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura
PaceData Entry: Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130084
Page 121 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada) (pfe.lpace) Exclusion Nu
mber:12
Criterion Desc
ription:Previous vaccination
with any coronaviru
s vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Previous vaccination with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusion
Number:13Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130085
Page 122 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy,
such as cytotoxic agents o
r systemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Subjects who receive immunosuppres
sive therapy, such as cytotoxic agents
or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi15Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130086
Page 123 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
on Nu
mber:
Criteri
on Desc
ription:Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study int
ervention administration or
planned receipt throughout t
he study
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before
study intervention administration or pl
anned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX14A01Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130087
Page 124 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
2.k
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studi
es involving study interven
tion within 28 days prior to
study entry and/or during s
tudy participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX15A01Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130088
Page 125 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.k Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participation in other studies involvin
g study intervention within 28 days pr
ior to study entry and/or during study
participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130089
Page 126 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Previous participation in other studies
involving study intervention containin
g lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130090
Page 127 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Des
criptio
n:Investigator site staff or Pfiz
er employees directly involv
ed in the conduct of the stud
y, site staff otherwise superv
ised by the investigator, and
their respective family mem
bers
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130091
Page 128 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.m Exclusion Number:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Investigator site staff or Pfizer emplo
yees directly involved in the conduct
of the study, site staff otherwise super
vised by the investigator, and their res
pective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 13:25:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX21A01Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130092
Page 129 of 201
***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: 10071101 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
Jul-30-2020 13:25:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-30-2020 13:25:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-30-2020 13:25:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130093
Page 130 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Jul-30-2020 13:29:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Obesity
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-30-2020 13:29:18
(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
Jul-30-2020 13:29:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ObesityInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-30-2020 13:29:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-30-2020 13:29:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130094
Page 131 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jul-30-2020 13:31:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Gastric sleeve
Start Date: Sep/UNK/2019
Ongoing: NO
End Date:
Sep/UNK/20
19Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Jul-30-2020 13:31:00
(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
Jul-30-2020 13:31:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Gastric sleeveInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-30-2020 13:31:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sep/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-30-2020 13:31:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Sep/UNK/2019Initial Entry
1.c
Date Location User Value Reason
Nov-12-2020 12:44:37 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130095
Page 132 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) Line/MH Numbe
r:3
Medical History
Term:Gastroesophageal
reflux
Start Date: UNK/UNK/2018
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Nov-12-2020 12:44:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-12-2020 12:44:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Gastroesophageal refluxInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-12-2020 12:44:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-12-2020 12:44:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Nov-12-2020 12:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Sleep apnea
Start Date: UNK/UNK/20
13Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130096
Page 133 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Nov-12-2020 12:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-12-2020 12:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sleep apneaInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-12-2020 12:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2013Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-12-2020 12:44:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Nov-13-2020 07:17:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Supraventricular ta
chycardia
Start Date: Oct/8/2019
Ongoing: UnknownInitial Entry
Nov-13-2020 07:17:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Num
ber:5updating
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130097
Page 134 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical Histor
y Term:Supraventricular ta
chycardia
Start Date: Oct/8/2019
Ongoing:
Nov-12-2020 12:48:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Supraventricular ta
chycardia
Start Date: Oct/8/2019
Ongoing: NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130098
Page 135 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Nov-12-2020 12:48:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-12-2020 12:48:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Supraventricular tachycardiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-12-2020 12:48:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/8/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-13-2020 09:21:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Query 1: Closed Response satisfies
query
Nov-13-2020 07:17:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
UnknownInitial Entry
Nov-13-2020 07:17:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered updating
Nov-13-2020 07:17:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry: updating
Nov-13-2020 02:14:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM: Since End Date
is unknown, kindly
update item level
comment as
Unknown from
dropdown list.
Nov-12-2020 12:48:55 ACV0PFEINFP6000 Laura Pace Data Entry: Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130099
Page 136 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)(pfe.lpace) NO
1.f
Date Location User Value Reason
Mar-10-2021 13:30:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Hypothyroidis
m
Start Date: Nov/UNK/20
07
Ongoing: YESChanged Information
Mar-09-2021 12:33:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Hypothyroidism
Start Date: Nov/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2
020Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130100
Page 137 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Mar-09-2021 12:33:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-09-2021 12:33:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jennifer
Wendell
(pfe.jwendell)Data Entry:
HypothyroidismInitial Entry
1.f Start Date:
Date Location User Value Reason
Mar-09-2021 12:33:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jennifer
Wendell
(pfe.jwendell)Data Entry:
Nov/UNK/2007Initial Entry
1.f Ongoing:
Date Location User Value Reason
Mar-10-2021
23:12:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clos
edAuto closed by Validation
Check:
VC_MH001_04_AN
Mar-10-2021
13:30:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredChanged Information
Mar-10-2021
13:30:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry:
YESChanged Information
Mar-10-2021
00:04:08
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW7650896;End Date' is
after ‘Date of
Completion/Discontinuation
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130101
Page 138 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time
(US &
Canada)/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Mar-09-2021
12:33:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jennifer Wendell
(pfe.jwendell)Data
Entry:
NO
End
Date:
UN
K/
UN
K/2
020Initial Entry
1.g
Date Location User Value Reason
Mar-10-2021 13:28:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Depression
Start Date: UNK/UNK/20
08
Ongoing: YESChanged Information
Mar-09-2021 12:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Depression
Start Date: UNK/UNK/200
8
Ongoing: NO
End Date:
UNK/UNK/2
020Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130102
Page 139 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.g Line/MH Number:
Date Location User Value Reason
Mar-09-2021 12:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-09-2021 12:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jennifer
Wendell
(pfe.jwendell)Data Entry:
DepressionInitial Entry
1.g Start Date:
Date Location User Value Reason
Mar-09-2021 12:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jennifer
Wendell
(pfe.jwendell)Data Entry:
UNK/UNK/2008Initial Entry
1.g Ongoing:
Date Location User Value Reason
Mar-10-2021
23:29:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: Cl
osedAuto closed by
Validation Check:
VC_MH001_04_AN
Mar-10-2021
13:28:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredChanged Information
Mar-10-2021
13:28:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entr
y:
YESChanged Information
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130103
Page 140 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.g Ongoing:
Date Location User ValueReason
Mar-10-2021
00:14:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7650897;End Date' is
after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Mar-09-2021
12:34:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jennifer Wendell
(pfe.jwendell)Data
Entry
:
NO
End
Date
:
U
N
K/
U
N
K/
20
20Initial Entry
1.h
Date Location User Value Reason
Mar-10-2021 13:30:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Number: 8
Medical History Ter
m:Asthma
Start Date: UNK/UNK/20
09
Ongoing: YESChanged Information
Mar-09-2021 12:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:Asthma
Start Date: UNK/UNK/200
9Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130104
Page 141 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: NO
End Date:
UNK/UNK/2
020
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130105
Page 142 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.h Line/MH Number:
Date Location User Value Reason
Mar-09-2021 12:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-09-2021 12:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jennifer
Wendell
(pfe.jwendell)Data Entry:
AsthmaInitial Entry
1.h Start Date:
Date Location User Value Reason
Mar-09-2021 12:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jennifer
Wendell
(pfe.jwendell)Data Entry:
UNK/UNK/2009Initial Entry
1.h Ongoing:
Date Location User Value Reason
Mar-10-2021
23:29:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clos
edAuto closed by Validation
Check:
VC_MH001_04_AN
Mar-10-2021
13:30:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredChanged Information
Mar-10-2021
13:30:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data
Entry:
YESChanged Information
Mar-10-2021
00:14:01
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW7650898;End Date' is
after ‘Date of
Completion/Discontinuation
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130106
Page 143 of 201
***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, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time
(US &
Canada)/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Mar-09-2021
12:35:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jennifer Wendell
(pfe.jwendell)Data
Entry:
NO
End
Date:
UN
K/
UN
K/2
020Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130107
Page 144 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
129.6Initial Entry
3. Unit:
Date Location User Value Reason
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
167.5Initial Entry
5. Unit:
Date Location User Value Reason
Jul-30-2020 13:28:15
(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
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
46.2Initial Entry
7.a
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130108
Page 145 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-30-2020 13:28:15
(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
Jul-30-2020 13:28:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130109
Page 146 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-18-2021 09:10:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
McGuire
(pfe.mcguim15)Query 1: Closed Response satisfies
query
Feb-17-2021 19:53:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered protocol deviations is
reported
Feb-11-2021 10:07:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
McGuire
(pfe.mcguim15)Query 1: Reissued:Opened CLINQUERY2 -
Thank you for your
response. Please
ensure PD is reported,
as WOCBP status
was not known at
time of visits.
Feb-10-2021 13:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered information not
obtained; subject is
deceased
Feb-09-2021 09:54:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Monica
McGuire
(pfe.mcguim15)Query 1: Opened CLINQUERY -
Pregnancy test was
reported as NOT
APPLICABLE at V1
and V2. However,
subject is <60 yrs old
and has no MH of
surgical sterilization.
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130110
Page 147 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Please confirm if
subject is WOCBP. If
reason exists that
tests were not
necessary, please
update MH.
Jul-30-2020 13:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
ble
Test:: Not Applica
ble
Result:: Not Applica
ble
Not Done:: Not Applica
bleInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130111
Page 148 of 201
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Test:
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jul-30-2020 13:26:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130112
Page 149 of 201
***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: 10071101 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-03-2020 15:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-03-2020 15:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
220496Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130113
Page 150 of 201
***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: 10071101 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
Jul-30-2020 13:25:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 13:25:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020 16:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 13:25:51
(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.
Jul-30-2020 13:25:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020 16:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM8993Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130114
Page 151 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jul-30-2020 16:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM8993Initial Entry
5.b
Date Location User Value Reason
Jul-30-2020 16:38:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM8994Initial Entry
5.b Sample ID
Date Location User Value Reason
Jul-30-2020 16:38:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM8994Initial Entry
5.c
Date Location User Value Reason
Jul-30-2020 16:38:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM8995Initial Entry
5.c Sample ID
Date Location User Value Reason
Jul-30-2020 16:38:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM8995Initial Entry
5.d
Date Location User Value Reason
Jul-30-2020 16:38:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPFZVBInitial Entry
5.d Sample ID
Date Location User Value Reason
Jul-30-2020 16:38:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZVBInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130115
Page 152 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.e
Date Location User Value Reason
Jul-30-2020 16:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPFZVCInitial Entry
5.e Sample ID
Date Location User Value Reason
Jul-30-2020 16:38:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZVCInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130116
Page 153 of 201
***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: 10071101 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
Jul-30-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020 16:38:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jul-30-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020 16:38:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM898VInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130117
Page 154 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jul-30-2020 16:38:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM898VInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130118
Page 155 of 201
***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: 10071101 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
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020 13:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130119
Page 156 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jul-30-2020 13:51:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130120
Page 157 of 201
***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: 10071101 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
Jul-30-2020 13:51:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJEC
TInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130121
Page 158 of 201
***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: 10071101 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-20-2020 11:00:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/20/2020Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130122
Page 159 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FAT
IGU
EInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130123
Page 160 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NO
2.b Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130124
Page 161 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.d
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was complet
ed?:NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130125
Page 162 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.e Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-20-2020 11:02:10 ACV0PFEINFP6000 Laura Data Entry: Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130126
Page 163 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)Pace
(pfe.lpace)Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130127
Page 164 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura
PaceData Entry:
REDNESSInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130128
Page 165 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada) (pfe.lpace)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
EInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130129
Page 166 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:02:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130130
Page 167 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 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-20-2020 11:01:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/20/2020Initial Entry
2.a
Date Location User Value Reason
Aug-20-2020 11:01:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 11:01:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-20-2020 11:01:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-20-2020 11:01:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 11:01:14 ACV0PFEINFP6000 Laura Data Entry: Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130131
Page 168 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)Pace
(pfe.lpace)ORAL CAVITY
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130132
Page 169 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
bleInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130133
Page 170 of 201
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 17-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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Test:: Not Applica
ble
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-20-2020 11:01:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130134
Page 171 of 201
***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: 10071101 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-20-2020 11:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 11:00:52
(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-20-2020 17:20:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 11:00:52
(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-20-2020 11:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 17:20:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP757YInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130135
Page 172 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-20-2020 17:20:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BP757YInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130136
Page 173 of 201
***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: 10071101 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-20-2020 11:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 11:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 11:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 11:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/20/2020 11:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 11:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 11:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130137
Page 174 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-20-2020 11:47:00
(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-20-2020 11:47:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-20-2020 14:17:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130138
Page 175 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 12:08:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sep/17/2020Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130139
Page 176 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FAT
IGU
EInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130140
Page 177 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NO
2.b Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130141
Page 178 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.d
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was complet
ed?:NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130142
Page 179 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.e Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-17-2020 12:09:27 ACV0PFEINFP6000 Laura Data Entry: Initial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130143
Page 180 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern Time
(US & Canada)Pace
(pfe.lpace)Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130144
Page 181 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Laura
PaceData Entry:
REDNESSInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130145
Page 182 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada) (pfe.lpace)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
EInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130146
Page 183 of 201
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 12:09:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130147
Page 184 of 201
***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: 10071101 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 12:08:43
(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 12:08:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 13:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 12:08:43
(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 12:08:43
(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 13:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTRJInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130148
Page 185 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020 13:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTRJInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020 13:04:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0HPInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020 13:04:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0HPInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020 13:04:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0HRInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020 13:04:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0HRInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130149
Page 186 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-10-2020
16:16:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 2: C
losedAuto closed by
Validation Check:
VC_DS001_21
Nov-10-2020
11:44:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: A
nsweredChanged Information
Nov-10-2020
11:44:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entr
y:
Sep/17/20
20Changed Information
Nov-10-2020
09:29:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 2: O
penedDMW5336791;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Nov-10-2020
02:04:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann Piojo
(pfe.quitor)Query 1: C
losedResponse satisfies
query
Nov-09-2020
07:05:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredTranscription Error
Nov-09-2020
07:05:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entr
y:
Oct/21/202
0Transcription Error
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130150
Page 187 of 201
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-07-2020
10:01:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann Piojo
(pfe.quitor)Query 1: R
eissued:Op
enedSAE RECON 1:Form
unfrozen, please
update accordingly.
Nov-06-2020
11:24:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: A
nsweredplease unfreeze so
correction can be
made
Nov-06-2020
05:36:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann Piojo
(pfe.quitor)Query 1: O
penedSAE RECON:
AER#2020434734,
the date of death was
reported as
21Oct2020 in Safety
database but recorded
as 17Sep2020 in
CRF. Please confirm
correct date of death.
If safety update is
required, please
submit a follow-up
form.
Sep-17-2020
12:09:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entr
y:
Sep/17/20
20Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020 12:09:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020 12:09:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae402c\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0130151
Page 188 of 201
***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: 10071101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-05-2020 16:40:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020 16:40:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-09-2020 08:29:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-05-2020 16:41:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-05-2020 16:40:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to "Status"
is DEATH but
"Specify Status" is
Provided.
Nov-05-2020 16:40:57
(UTC-05:00)
…[truncated]