Document text
Page 1 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129716
Page 2 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129717
Page 3 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071097]
2.Birth Date: /1971
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:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0129718
Page 4 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129719
Page 5 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129720
Page 6 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129721
Page 7 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129722
Page 8 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129723
Page 9 of 249
***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: 10071097 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: [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129724
Page 10 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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:[Depression]
Start Date: UNK/UNK/1999
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal allergy]
Start Date: UNK/UNK/1985
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: Feb/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to antibiotic erythromycin]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129725
Page 11 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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:[LASIK eye surgery]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraine]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129726
Page 12 of 249
***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: 10071097 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: [100.5]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [34.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129727
Page 13 of 249
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129728
Page 14 of 249
***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: 10071097 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: [40427]
3.Randomization Group: [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129729
Page 15 of 249
***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: 10071097 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 [BM898K]
5.bSample ID [BM898L]
5.cSample ID [BM898M]
5.dSample ID [BPFZV2]
5.eSample ID [BPFZV3]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129730
Page 16 of 249
***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: 10071097 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 [BM898H]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129731
Page 17 of 249
***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: 10071097 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 11:42
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129732
Page 18 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129733
Page 19 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129734
Page 20 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129735
Page 21 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129736
Page 22 of 249
***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: 10071097 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: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129737
Page 23 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/20/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129738
Page 24 of 249
***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: 10071097 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 [BP757N]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129739
Page 25 of 249
***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: 10071097 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 09:54
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129740
Page 26 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129741
Page 27 of 249
***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: 10071097 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?YES
Ongoing?
NO
Stop Date:
Aug/26/2020
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129742
Page 28 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?YES
Ongoing?
NO
Stop Date:
Sep/1/2020
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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129743
Page 29 of 249
***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: 10071097 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 [BPYTRF]
5.bSample ID [BPG0HH]
5.cSample ID [BPG0HJ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129744
Page 30 of 249
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129745
Page 31 of 249
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/22/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0ZW4]
5.bSample ID [BNWN3D]
5.cSample ID [BNWN3G]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129746
Page 32 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129747
Page 33 of 249
***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: 10071097 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 [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129748
Page 34 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129749
Page 35 of 249
***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: 10071097 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 [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129750
Page 36 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129751
Page 37 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/28/2020
2.Date of First Symptom Started: Oct/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/27/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129752
Page 38 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [headache]
5.bSymptoms - Other Text: [fatigue]
5.cSymptoms - Other Text: [loss of appetite]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129753
Page 39 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Lo
cationAssay Code and Descri
ptionDevice Type Form Instance
1.Not Applicable
Not Applica
ble Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129754
Page 40 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129755
Page 41 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
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 [RW81430]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129756
Page 42 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject did not come in; did self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129757
Page 43 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129758
FDA-CBER-2021-5683-0129759
Page 45 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129760
Page 46 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129761
FDA-CBER-2021-5683-0129762
Page 48 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129763
Page 49 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129764
Page 50 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129765
Page 51 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129766
Page 52 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129767
FDA-CBER-2021-5683-0129768
Page 54 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129769
FDA-CBER-2021-5683-0129770
Page 56 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129771
FDA-CBER-2021-5683-0129772
Page 58 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129773
Page 59 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129774
Page 60 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
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FDA-CBER-2021-5683-0129776
Page 62 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
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FDA-CBER-2021-5683-0129777
Page 63 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129778
Page 64 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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:
Nov/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 [BP90FD]
5.bSample ID [BMRW8L]
5.cSample ID [BMRW8M]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129779
Page 65 of 249
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/21/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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/21/2020
2.Erroneous Visit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129780
Page 66 of 249
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/21/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129781
Page 67 of 249
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/21/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/21/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
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FDA-CBER-2021-5683-0129782
Page 68 of 249
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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: [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129783
Page 69 of 249
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0129784
Page 70 of 249
***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: 10071097 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:
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FDA-CBER-2021-5683-0129785
Page 71 of 249
***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: 10071097 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 [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129786
Page 72 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Right Scapular Muscle Pai
n Aug/21/2020 12:
00 NO
End Date Time:
Sep/1/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 Bilateral Swollen Cervical
Lymph Nodes Aug/23/2020 U
NK:UNK NO
End Date Time:
Sep/3/2020 UNK:UN
K
Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129787
Page 73 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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)[Right Scapular Muscle Pain]
4.Start Date Time: Aug/21/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/1/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[possible muscle spasm. Unclear exact etiology]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129788
Page 74 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129789
Page 75 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Bilateral Swollen Cervical Lymph Nodes]
4.Start Date Time: Aug/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/3/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Possible viral syndrome]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
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Page 76 of 249
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129791
Page 77 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129792
Page 78 of 249
***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: 10071097 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[ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129793
Page 79 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129794
Page 80 of 249
***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: 10071097 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: //
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129795
Page 81 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129796
Page 82 of 249
***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: 10071097 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?
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129797
FDA-CBER-2021-5683-0129798
Page 84 of 249
***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: 10071097 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?
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129799
FDA-CBER-2021-5683-0129800
Page 86 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129801
Page 87 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129802
Page 88 of 249
***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: 10071097 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:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129803
Page 89 of 249
***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: 10071097 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:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129804
Page 90 of 249
***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: 10071097 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?
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129805
Page 91 of 249
***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: 10071097 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: [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129806
Page 92 of 249
***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: 10071097 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: [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129807
Page 93 of 249
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129808
Page 94 of 249
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129809
Page 95 of 249
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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 [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129810
Page 96 of 249
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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 [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129811
Page 97 of 249
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129812
Page 98 of 249
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129813
Page 99 of 249
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129814
Page 100 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129815
Page 101 of 249
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129816
Page 102 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/17/2020
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129817
Page 103 of 249
***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: 10071097 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
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129818
Page 104 of 249
***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: 10071097 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-07-2021 21:22:19 (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.
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129819
Page 105 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormOct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129820
Page 106 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129821
Page 107 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129822
Page 108 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129823
Page 109 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129824
Page 110 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129825
Page 111 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129826
Page 112 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
7Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129827
Page 113 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
8Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129828
Page 114 of 249
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
9Oct-29-2020 11:56:48 (UTC-05:00) Eastern
Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129829
Page 115 of 249
***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: 10071097 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-07-2021 21:22:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Laura Pace N/A Feb-18-2021 22:59:57 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Dec-20-2020 22:53:31 (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 Dec-09-2020 17:47:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129830
Page 116 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Robert Frenck Approved Dec-02-2020 16:24:15 (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-30-2020 16:31:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Oct-30-2020 11:58:59 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Laura Pace N/A Oct-29-2020 11:50:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Sep-22-2020 11:34:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129831
Page 117 of 249
***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: 10071097 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 Sep-21-2020 11:51:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Sep-18-2020 17:14:57 (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-18-2020 13:03:14 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Sep-17-2020 20:46:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129832
Page 118 of 249
***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: 10071097 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 Sep-17-2020 09:52:09 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Frenck Approved Aug-28-2020 16:10:18 (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.
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129833
Page 119 of 249
***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: 10071097 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 11:12:49
(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 11:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129834
Page 120 of 249
***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: 10071097 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 11:12:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/30/2020Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129835
Page 121 of 249
***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: 10071097 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 11:12:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071097Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-30-2020 11:12:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1971Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-30-2020 11:13:17
(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 11:13:17
(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 11:13:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
FDA-CBER-2021-5683-0129836
Page 122 of 249
***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: 10071097 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 11:13:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129837
Page 123 of 249
***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: 10071097 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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participan
ts between the ages of 18
and 55 years, inclusive, 6
5 and 85 years, inclusive,
or 18 and 85 years, inclusi
ve, at randomization (dep
endent upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, inc
lusive, 65 and 85 years, inclusive,
or 18 and 85 years, inclusive, at raInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129838
Page 124 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
ndomization (dependent upon stud
y stage)
1.a Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(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 willi
ng and able to comply wi
th all scheduled visits, va
ccination plan, laboratory
tests, lifestyle considerati
ons, and other study proc
edures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129839
Page 125 of 249
***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: 10071097 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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participants who are willing and a
ble to comply with all scheduled v
isits, vaccination plan, laboratory t
ests, lifestyle considerations, and o
ther study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129840
Page 126 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgme
nt of the investigator to b
e eligible for inclusion in
the study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129841
Page 127 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Inclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgmen
t of the investigator to be eligible f
or inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129842
Page 128 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compli
ance with the requiremen
ts and restrictions listed i
n the ICD and in this prot
ocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129843
Page 129 of 249
***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: 10071097 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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129844
Page 130 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or active
suicidal ideation/behavior
/lab abnormality that may
increase the risk of study
participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Other medical or psychiatric condi
tion incl. recent (within past year)
or active suicidal ideation/behavio
r/lab abnormality that may increas
e the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129845
Page 131 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129846
Page 132 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.b Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Known infection with human imm
unodeficiency virus (HIV), hepatit
is C virus (HCV), or hepatitis B vi
rus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-30-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129847
Page 133 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component o
f the study intervention(s
)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129848
Page 134 of 249
***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: 10071097 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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
History of severe adverse reaction
associated with a vaccine and/or se
vere allergic reaction (eg, anaphyl
axis) to any component of the stud
y intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129849
Page 135 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129850
Page 136 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodeficie
ncy, as determined by his
tory and/or laboratory/ph
ysical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129851
Page 137 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.e Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by histor
y and/or laboratory/physical exami
nationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129852
Page 138 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pro
longed bleeding that wou
ld, in the opinion of the i
nvestigator, contraindicat
e intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129853
Page 139 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding th
at would, in the opinion of the inv
estigator, contraindicate intramusc
ular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-30-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeedingInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129854
Page 140 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criterion met
?:NO
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Women who are pregnant or breast
feedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusion Nu
mber:12Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129855
Page 141 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criterion Des
cription:Previous vaccinati
on with any coron
avirus vaccine
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129856
Page 142 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jul-30-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic corti
costeroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129857
Page 143 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.i Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Subjects who receive immunosupp
ressive therapy, such as cytotoxic
agents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi
on Nu
mber:15Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129858
Page 144 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admini
stration or planned receip
t throughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129859
Page 145 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.j Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention administ
ration or planned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX14A01Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129860
Page 146 of 249
***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: 10071097 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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusi
on Num
ber:16
Criteri
on Desc
ription:Participation in other st
udies involving study in
tervention within 28 day
s prior to study entry an
d/or during study partici
pation
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX15A01Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129861
Page 147 of 249
***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: 10071097 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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participation in other studies invol
ving study intervention within 28
days prior to study entry and/or du
ring study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numbe
r:17Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129862
Page 148 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Criterion
Descripti
on:Previous participation
in other studies involvi
ng study intervention c
ontaining lipid nanopa
rticles
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Previous participation in other stu
dies involving study intervention
containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX16A01Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129863
Page 149 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.m
Date Location User Value Reason
Jul-30-2020 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff other
wise supervised by the in
vestigator, and their respe
ctive family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129864
Page 150 of 249
***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: 10071097 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 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Investigator site staff or Pfizer em
ployees directly involved in the co
nduct of the study, site staff other
wise supervised by the investigato
r, and their respective family mem
bersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-30-2020 11:44:37
(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 11:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX21A01Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129865
Page 151 of 249
***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: 10071097 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 11:44:47
(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 11:44:47
(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 11:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129866
Page 152 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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 11:48:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Depression
Start Date: UNK/UNK/1
999
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-30-2020 11:48:55
(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 11:48:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
DepressionInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-30-2020 11:48:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1999Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-30-2020 11:48:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129867
Page 153 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b
Date Location User Value Reason
Jul-30-2020 11:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Seasonal aller
gy
Start Date: UNK/UNK/1
985
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Jul-30-2020 11:49:25
(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 11:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Seasonal allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-30-2020 11:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1985Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-30-2020 11:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.c
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129868
Page 154 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jul-30-2020 11:50:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:Insomnia
Start Date: Feb/UNK/20
20
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Jul-30-2020 11:50:01
(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
Jul-30-2020 11:50:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
InsomniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-30-2020 11:50:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jul-30-2020 11:50:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Jul-30-2020 11:50:47 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129869
Page 155 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Nu
mber:4
Medical Hist
ory Term:Allergy to antibioti
c erythromycin
Start Date: UNK/UNK/2001
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Jul-30-2020 11:50:47
(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
Jul-30-2020 11:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Allergy to antibiotic erythromycinInitial Entry
1.d Start Date:
Date Location User Value Reason
Jul-30-2020 11:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2001Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jul-30-2020 11:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jul-30-2020 11:51:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129870
Page 156 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Medical History
Term:LASIK eye sur
gery
Start Date: UNK/UNK/20
06
Ongoing: NO
End Date:
UNK/UNK/
2006
1.e Line/MH Number:
Date Location User Value Reason
Jul-30-2020 11:51:19
(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
Jul-30-2020 11:51:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LASIK eye surgeryInitial Entry
1.e Start Date:
Date Location User Value Reason
Jul-30-2020 11:51:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2006Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jul-30-2020 11:51:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.f
Date Location User Value Reason
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129871
Page 157 of 249
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-27-2020 13:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Migraine
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-27-2020 13:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 13:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
MigraineInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-27-2020 13:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2002Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-27-2020 13:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129872
Page 158 of 249
***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: 10071097 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 11:47:38
(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 11:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
100.5Initial Entry
3. Unit:
Date Location User Value Reason
Jul-30-2020 11:47:38
(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 11:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
172.0Initial Entry
5. Unit:
Date Location User Value Reason
Jul-30-2020 11:47:38
(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 11:47:38
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.0Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129873
Page 159 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
7.a
Date Location User Value Reason
Jul-30-2020 11:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-30-2020 11:47:38
(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 11:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-30-2020 11:47:38
(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 11:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129874
Page 160 of 249
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 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 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129875
Page 161 of 249
***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, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center
Subject No: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jul-30-2020 11:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129876
Page 162 of 249
***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: 10071097 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 13:47:44
(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 13:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
40427Transcription Error
Aug-03-2020 13:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
220496Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129877
Page 163 of 249
***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: 10071097 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 11:45:00
(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 11:45:00
(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 16:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 11:45:00
(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 11:45:00
(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 16:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM898KInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129878
Page 164 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Jul-30-2020 16:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM898KInitial Entry
5.b
Date Location User Value Reason
Jul-30-2020 16:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM898LInitial Entry
5.b Sample ID
Date Location User Value Reason
Jul-30-2020 16:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM898LInitial Entry
5.c
Date Location User Value Reason
Jul-30-2020 16:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM898MInitial Entry
5.c Sample ID
Date Location User Value Reason
Jul-30-2020 16:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM898MInitial Entry
5.d
Date Location User Value Reason
Jul-30-2020 16:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPFZV2Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129879
Page 165 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Sample ID
Date Location User Value Reason
Jul-30-2020 16:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZV2Initial Entry
5.e
Date Location User Value Reason
Jul-30-2020 16:32:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPFZV3Initial Entry
5.e Sample ID
Date Location User Value Reason
Jul-30-2020 16:32:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZV3Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129880
Page 166 of 249
***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: 10071097 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 11:45:09
(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 11:45:09
(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 16:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 11:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jul-30-2020 11:45:09
(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 16:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM898HInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129881
Page 167 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Jul-30-2020 16:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM898HInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129882
Page 168 of 249
***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: 10071097 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 12:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-30-2020 12:16:55
(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 12:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-30-2020 12:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jul/30/2020 11:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-30-2020 12:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-30-2020 12:16:55
(UTC-05:00) EasternACV0PFEINFP6000 Laura
PaceData Entry:
LEFTInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129883
Page 169 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.lpace)
7. Route:
Date Location User Value Reason
Jul-30-2020 12:16:55
(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 12:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jul-30-2020 12:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129884
Page 170 of 249
***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: 10071097 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 12:17:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129885
Page 171 of 249
***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: 10071097 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 09:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/20/2020Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129886
Page 172 of 249
***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: 10071097 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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FAInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129887
Page 173 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129888
Page 174 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.c Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-20-2020 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129889
Page 175 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-20-2020 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129890
Page 176 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129891
Page 177 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.g Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial 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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-20-2020 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED JOINT P
AINInitial 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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129892
Page 178 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
3. Injection Site Location:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129893
Page 179 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-20-2020 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129894
Page 180 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 09:24:09
(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 09:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129895
Page 181 of 249
***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: 10071097 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 09:23:02
(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 09:23:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 09:23:02
(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 09:23:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-20-2020 09:23:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129896
Page 182 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-20-2020 09:23:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129897
Page 183 of 249
***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: 10071097 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 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129898
Page 184 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020 09:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEGATIVEInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129899
Page 185 of 249
***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: 10071097 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 09:23:28
(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 09:23:28
(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 17:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 09:23:28
(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 09:23:28
(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 17:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP757NInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129900
Page 186 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 17:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BP757NInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129901
Page 187 of 249
***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: 10071097 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 10:03:51
(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 10:03:51
(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 10:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Aug-26-2020
11:17:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Cavin van Schalkwyk
(pfe.vanscc01)Query
1: Clo
sedResponse satisfies
query
Aug-25-2020
09:12:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Query
1: An
swere
dconfirmed
Aug-25-2020
02:09:57
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
1: Op
enedSubject has
reported with
Severe
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129902
Page 188 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time
(US &
Canada)symptoms/reactions
on '2020-08-21'.
Per protocol,
subjects
experiencing Grade
3 local reactions
should be
contacted. Please
confirm if an
UNPLANNED
CONTACT was
made and update
the corresponding
form as
appropriate.
"[newtod07
SDQ=985]"
Aug-20-2020
10:03:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Laura Pace (pfe.lpace) Data
Entry
:
Aug/2
0/202
0 09:5
4Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 10:03:51
(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 10:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020 10:03:51 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129903
Page 189 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020 10:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-20-2020 10:30:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129904
Page 190 of 249
***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: 10071097 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 09:52:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sep/17/2020Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129905
Page 191 of 249
***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: 10071097 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-18-2020 13:03:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/26/2020New Information
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES
Ongoing?
YESInitial Entry
2.a
Date Location User Value Reason
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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?
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129906
Page 192 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FA
TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129907
Page 193 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NO
2.c Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129908
Page 194 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.d Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129909
Page 195 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW OR W
ORSENED
MUSCLE PA
INInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129910
Page 196 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:YES
Ongoing?
NO
Stop Dat
e:
Sep/1/
2020
2.g Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial 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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/1/2020Initial Entry
2.h
Date Location User Value Reason
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAINInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129911
Page 197 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NO
2.h Symptom:
Date Location User Value Reason
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED JOINT P
AINInitial 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 15:41:19
(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 15:41:19
(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 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: RE
DN
ESSInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129912
Page 198 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-17-2020 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129913
Page 199 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-17-2020 15:41:19
(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 15:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129914
Page 200 of 249
***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: 10071097 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 09:52:17
(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 09:52:17
(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 13:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 09:52:17
(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 09:52:17
(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 13:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPYTRFInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129915
Page 201 of 249
***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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 13:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPYTRFInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020 13:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0HHInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020 13:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0HHInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020 13:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG0HJInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020 13:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPG0HJInitial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129916
Page 202 of 249
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-22-2021 11:51:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Feb/22/2021Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129917
Page 203 of 249
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 10071097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-22-2021 11:51:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-22-2021 11:51:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021 11:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-22-2021 11:51:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-22-2021 11:51:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Feb/22/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021 11:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Morgan
Messeder
(pfe.mmesseder)Data Entry:
Sample ID: BR0ZW4Initial Entry
090177e196ae402e\Final\Final On: 01-Apr-2021 05:32 (GMT)
FDA-CBER-2021-5683-0129918
Page 204 of 249
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: E
…[truncated]