Document text
Page 1 of 341
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130166
Page 2 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/3/2020
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130167
Page 3 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071117]
2.Birth Date: /1974
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:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130168
Page 4 of 341
***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: 10071117 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/3/2020
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130169
Page 5 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130170
Page 6 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130171
Page 7 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130172
Page 8 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130173
Page 9 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130174
Page 10 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130175
Page 11 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130176
Page 12 of 341
***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: 10071117 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:[Seasonal asthma]
Start Date: UNK/UNK/1991
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Migraine]
Start Date: UNK/UNK/1982
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Drug allergy demerol]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130177
Page 13 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Drug allergy ferrous sulfate]
Start Date: UNK/UNK/1974
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Latex allergy]
Start Date: UNK/UNK/1974
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Dilation and curettage]
Start Date: May/UNK/2019
Ongoing: NO
End Date:
May/UNK/2019
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130178
Page 14 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hysterectomy]
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
Dec/UNK/2019
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130179
Page 15 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/3/2020
2.Weight: [90.4]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [30.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130180
Page 16 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130181
Page 17 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/3/2020
2.Randomization Number: [41898]
3.Randomization Group: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130182
Page 18 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM89DR]
5.bSample ID [BM89DS]
5.cSample ID [BM89DT]
5.dSample ID [BPFZXL]
5.eSample ID [BPFZXM]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130183
Page 19 of 341
***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: 10071117 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/3/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM89D8]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130184
Page 20 of 341
***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: 10071117 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/3/2020 15:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130185
Page 21 of 341
***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: 10071117 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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130186
Page 22 of 341
***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: 10071117 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/24/2020
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130187
Page 23 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130188
Page 24 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130189
Page 25 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130190
Page 26 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130191
Page 27 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130192
Page 28 of 341
***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: 10071117 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/24/2020
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 [BP75DB]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130193
Page 29 of 341
***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: 10071117 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/24/2020 14:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130194
Page 30 of 341
***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: 10071117 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/21/2020
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130195
Page 31 of 341
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130196
Page 32 of 341
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130197
Page 33 of 341
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130198
Page 34 of 341
***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: 10071117 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/21/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYTS5]
5.bSample ID [BMPS9F]
5.cSample ID [BMPS9G]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130199
Page 35 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130200
Page 36 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130201
Page 37 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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 [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130202
Page 38 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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 [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130203
Page 39 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130204
Page 40 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130205
Page 41 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130206
Page 42 of 341
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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 [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130207
Page 43 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130208
Page 44 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130209
Page 45 of 341
***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: 10071117 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130210
Page 46 of 341
***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: 10071117 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: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130211
Page 47 of 341
***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: 10071117 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:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130212
Page 48 of 341
***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: 10071117 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 [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130213
Page 49 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 chills Mar/9/2021
07:00 NO
End Date Time:
Mar/9/2021 12:0
0
Repeating
Pages
2.ADVERS
E EVENT
2 myalgias Mar/9/2021
07:00 NO
End Date Time:
Mar/9/2021 12:0
0
Repeating
Pages
3.ADVERS
E EVENT
3 right supraclavicular
swollen lymph node
Mar/9/2021
UNK:UNK YES Repeating
Pages
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130214
Page 50 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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)[chills]
4.Start Date Time: Mar/9/2021 07:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/9/2021 12:00
6.Toxicity Grade: 1
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130215
Page 51 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130216
Page 52 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130217
Page 53 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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)[myalgias]
4.Start Date Time: Mar/9/2021 07:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/9/2021 12:00
6.Toxicity Grade: 1
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130218
Page 54 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130219
Page 55 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130220
Page 56 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[right supraclavicular swollen lymph node]
4.Start Date Time: Mar/9/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130221
Page 57 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130222
Page 58 of 341
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130223
Page 59 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130224
Page 60 of 341
***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: 10071117 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[ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130225
Page 61 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130226
Page 62 of 341
***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: 10071117 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: //
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130227
Page 63 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130228
Page 64 of 341
***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: 10071117 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?
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130229
Page 65 of 341
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130230
Page 66 of 341
***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: 10071117 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?
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130231
FDA-CBER-2021-5683-0130232
Page 68 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130233
Page 69 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130234
Page 70 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10071117 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:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130235
Page 71 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10071117 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:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130236
Page 72 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10071117 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?
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130237
Page 73 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10071117 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: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130238
Page 74 of 341
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10071117 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: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130239
Page 75 of 341
***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: 10071117 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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130240
Page 76 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130241
Page 77 of 341
***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: 10071117 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/11/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130242
Page 78 of 341
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Applicable
//Comments
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130243
Page 79 of 341
***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: 10071117 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: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130244
Page 80 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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/15/2021
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130245
Page 81 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/15/2021
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130246
Page 82 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130247
Page 83 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130248
Page 84 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130249
Page 85 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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/15/2021
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 [BR0ZPG]
5.bSample ID [BNWMZW]
5.cSample ID [BNWMZX]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130250
Page 86 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/15/2021
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 [BR0ZPB]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130251
Page 87 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/15/2021 11:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130252
Page 88 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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 Mar/8/2021
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130253
Page 89 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130254
Page 90 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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:
Mar/8/2021
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 [BRB5T2]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130255
Page 91 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/8/2021 13:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130256
Page 92 of 341
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130257
Page 93 of 341
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130258
Page 94 of 341
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130259
Page 95 of 341
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130260
Page 96 of 341
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130261
Page 97 of 341
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130262
Page 98 of 341
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130263
Page 99 of 341
***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: 10071117 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/21/2020
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130264
Page 100 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130265
Page 101 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Frenck Approved Mar-10-2021 21:54:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130266
Page 102 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130267
Page 103 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Aug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130268
Page 104 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Aug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130269
Page 105 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130270
Page 106 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Aug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130271
Page 107 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Aug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130272
Page 108 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130273
Page 109 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130274
Page 110 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-03-2020 15:29:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130275
Page 111 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130276
Page 112 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Aug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130277
Page 113 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Aug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130278
Page 114 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130279
Page 115 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Aug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130280
Page 116 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Aug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130281
Page 117 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130282
Page 118 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130283
Page 119 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-24-2020 14:54:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130284
Page 120 of 341
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-16-2021 07:26:41 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130285
Page 121 of 341
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Feb-16-2021 07:26:41 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130286
Page 122 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-15-2021 10:44:26 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130287
Page 123 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130288
Page 124 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Feb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130289
Page 125 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Feb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130290
Page 126 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Feb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130291
Page 127 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Feb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130292
Page 128 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Feb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130293
Page 129 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130294
Page 130 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130295
Page 131 of 341
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-15-2021 11:31:40 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130296
Page 132 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormMar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130297
Page 133 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Mar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130298
Page 134 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Mar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130299
Page 135 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Mar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130300
Page 136 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Mar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130301
Page 137 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Mar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130302
Page 138 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aMar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130303
Page 139 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aMar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130304
Page 140 of 341
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aMar-08-2021 13:22:12 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130305
Page 141 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Frenck Approved Mar-10-2021 21:54:17 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Laura Pace N/A Mar-10-2021 15:20:32 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Mar-08-2021 20:53:45 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130306
Page 142 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 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 Mar-08-2021 13:21:56 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Mar-07-2021 21:31:57 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130307
Page 143 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 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 Feb-16-2021 07:26:41 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Feb-15-2021 22:11:39 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130308
Page 144 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 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 Feb-15-2021 10:42:49 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-22-2020 11:37:58 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130309
Page 145 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 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.
Jesse
LePage N/A Sep-21-2020 11:57:09 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-21-2020 11:07:33 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130310
Page 146 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 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 09:08:34 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-10-2020 14:53:57 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130311
Page 147 of 341
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10071117 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.
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130312
Page 148 of 341
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-03-2020
14:55:31
(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
Aug-03-2020
14:55:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130313
Page 149 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-03-2020
14:55:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/3/2020Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130314
Page 150 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-03-2020
14:55:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071117Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-03-2020
14:55:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-03-2020
14:55:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130315
Page 151 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
14:55:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-03-2020
14:55:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130316
Page 152 of 341
***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: 10071117 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-03-2020
14:56:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/3/2020Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130317
Page 153 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Incl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Male or female
participants bet
ween the ages of
18 and 55 years,
inclusive, 65 an
d 85 years, inclu
sive, or 18 and 8
5 years, inclusiv
e, at randomizati
on (dependent u
pon study stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130318
Page 154 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Male or female partici
pants between the ages
of 18 and 55 years, inc
lusive, 65 and 85 years
, inclusive, or 18 and 8
5 years, inclusive, at ra
ndomization (depende
nt upon study stage)Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130319
Page 155 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.a Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Incl
usio
n Nu
mbe
r:2Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130320
Page 156 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n De
scrip
tion:Participants wh
o are willing an
d able to compl
y with all sched
uled visits, vacc
ination plan, lab
oratory tests, lif
estyle considera
tions, and other
study procedure
s
Crit
erio
n me
t?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer u
se o
nly):IN02A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130321
Page 157 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Inclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participants who are w
illing and able to comp
ly with all scheduled vi
sits, vaccination plan, l
aboratory tests, lifestyl
e considerations, and o
ther study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130322
Page 158 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Incl
usio
n Nu
mbe
r:3
Crit
erio
n De
scrip
tion:Healthy particip
ants who are det
ermined by med
ical history, phy
sical examinatio
n, and clinical j
udgment of the i
nvestigator to b
e eligible for inc
lusion in the stu
dy
Crit
erio
n me
t?:YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130323
Page 159 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130324
Page 160 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Inclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Healthy participants w
ho are determined by
medical history, physic
al examination, and cli
nical judgment of the i
nvestigator to be eligib
le for inclusion in the s
tudyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130325
Page 161 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Incl
usio
n Nu
mbe
r:4
Crit
erio
n De
scrip
tion:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes complia
nce with the req
uirements and r
estrictions listed
in the ICD and i
n this protocol
Crit
erio
n me
t?:YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130326
Page 162 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):IN04A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130327
Page 163 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Inclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Capable of giving pers
onal signed informed c
onsent, which includes
compliance with the re
quirements and restrict
ions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130328
Page 164 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-03-2020
15:28:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical o
r psychiatric co
ndition incl. rec
ent (within past
year) or active s
uicidal ideation/
behavior/lab ab
normality that
may increase th
e risk of study p
articipation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130329
Page 165 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX01A00
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical o
r psychiatric co
ndition incl. rec
ent (within past
year) or active s
uicidal ideation/
behavior/lab ab
normality that
may increase th
e risk of study p
articipation
Crit
erio
n m
et?:Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130330
Page 166 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Other medical or psyc
hiatric condition incl. r
ecent (within past year
) or active suicidal idea
tion/behavior/lab abno
rmality that may increa
se the risk of study par
ticipationInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130331
Page 167 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.a Criterion met?
Date Location User Value Reason
Aug-03-2020
15:28:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130332
Page 168 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crite
rion
Descr
iption
:Known infecti
on with human
immunodeficie
ncy virus (HIV
), hepatitis C vi
rus (HCV), or
hepatitis B viru
s (HBV)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX02A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130333
Page 169 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.b Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Known infection with
human immunodeficie
ncy virus (HIV), hepati
tis C virus (HCV), or h
epatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130334
Page 170 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n Nu
mbe
r:3
Crit
erio
n De
scrip
tion:History of sever
e adverse reacti
on associated w
ith a vaccine an
d/or severe aller
gic reaction (eg,
anaphylaxis) to
any component
of the study inte
rvention(s)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130335
Page 171 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX03A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130336
Page 172 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.c Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
History of severe adve
rse reaction associated
with a vaccine and/or s
evere allergic reaction
(eg, anaphylaxis) to an
y component of the stu
dy intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130337
Page 173 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numb
er:4
Criterio
n Descri
ption:Receipt of
medications
intended to
prevent CO
VID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX04A00Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130338
Page 174 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.d Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Receipt of medications
intended to prevent C
OVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130339
Page 175 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n Nu
mbe
r:8
Crite
rion
Desc
ripti
on:Immunocompro
mised individua
ls with known o
r suspected im
munodeficiency
, as determined
by history and/
or laboratory/p
hysical examin
ation
Crite
rion
met?
:NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130340
Page 176 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crite
rion
ID: (
For
Pfize
r use
only)
:EX08A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130341
Page 177 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.e Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Immunocompromised
individuals with know
n or suspected immuno
deficiency, as determin
ed by history and/or la
boratory/physical exa
minationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130342
Page 178 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scrip
tion:Bleeding diathe
sis or condition
associated with
prolonged bleed
ing that would,
in the opinion o
f the investigato
r, contraindicate
intramuscular i
njection
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130343
Page 179 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX10A00
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130344
Page 180 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Bleeding diathesis or c
ondition associated wit
h prolonged bleeding t
hat would, in the opini
on of the investigator,
contraindicate intramu
scular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130345
Page 181 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numbe
r:11
Criterion
Descripti
on:Women wh
o are pregn
ant or brea
stfeeding
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX11A00Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130346
Page 182 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.g Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Women who are pregn
ant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130347
Page 183 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous va
ccination w
ith any coro
navirus vac
cine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX12A00Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130348
Page 184 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Previous vaccination w
ith any coronavirus va
ccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130349
Page 185 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion
Numb
er:13
Criter
ion D
escrip
tion:Subjects who r
eceive immun
osuppressive t
herapy, such a
s cytotoxic age
nts or systemic
corticosteroids
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130350
Page 186 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.i Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic cort
icosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130351
Page 187 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of bloo
d/plasma produ
cts or immunog
lobulin, from 6
0 days before st
udy interventio
n administratio
n or planned rec
eipt throughout
the study
Crit
erio
n me
t?:NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130352
Page 188 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX14A01
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130353
Page 189 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.j Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Receipt of blood/plasm
a products or immunog
lobulin, from 60 days
before study interventi
on administration or pl
anned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130354
Page 190 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX14A01Initial Entry
2.k
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
riptio
n:Participation in
other studies in
volving study i
ntervention wit
hin 28 days pri
or to study entr
y and/or during
study participat
ion
Crite
rion
met?
:NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130355
Page 191 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX15A01
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130356
Page 192 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.k Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Participation in other s
tudies involving study
intervention within 28
days prior to study entr
y and/or during study p
articipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130357
Page 193 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion N
umbe
r:17
Criter
ion De
scripti
on:Previous parti
cipation in oth
er studies invo
lving study int
ervention cont
aining lipid na
noparticles
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX16A01Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130358
Page 194 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.l Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Previous participation i
n other studies involvi
ng study intervention c
ontaining lipid nanopar
ticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130359
Page 195 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n N
umb
er:22
Crit
erio
n De
scri
ptio
n:Investigator site
staff or Pfizer e
mployees directl
y involved in th
e conduct of the
study, site staff
otherwise super
vised by the inv
estigator, and th
eir respective fa
mily members
Crit
erio
n m
et?:NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130360
Page 196 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX21A01
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130361
Page 197 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.m Exclusion Number:
Date Location User Value Reason
Aug-03-2020
15:27:47
(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
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Investigator site staff o
r Pfizer employees dire
ctly involved in the co
nduct of the study, site
staff otherwise supervi
sed by the investigator,
and their respective fa
mily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130362
Page 198 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
15:27:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX21A01Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130363
Page 199 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-03-2020
15:27:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-03-2020
15:27:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-03-2020
15:27:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130364
Page 200 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Aug-03-2020
15:31:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Seasonal
asthma
Start Date: UNK/U
NK/199
1
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-03-2020
15:31:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
15:31:09
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Seasonal asthmaInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130365
Page 201 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-03-2020
15:31:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1991Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-03-2020
15:31:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-03-2020
15:31:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Migraine
Start Date: UNK/U
NK/1982Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130366
Page 202 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoing: YES
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130367
Page 203 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Aug-03-2020
15:31:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
15:31:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
MigraineInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-03-2020
15:31:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1982Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130368
Page 204 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:31:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-03-2020
15:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical Hi
story Term
:Drug aller
gy demer
ol
Start Date: UNK/UN
K/2001
Ongoing: YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130369
Page 205 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Aug-03-2020
15:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
15:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Drug allergy demerolInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-03-2020
15:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2001Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130370
Page 206 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:31:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-03-2020
15:32:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Drug allerg
y ferrous s
ulfate
Start Dat
e:UNK/UNK
/1974
Ongoing: YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130371
Page 207 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Aug-03-2020
15:32:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
15:32:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Drug allergy ferrous su
lfateInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-03-2020
15:32:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1974Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130372
Page 208 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:32:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-03-2020
15:33:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Latex all
ergy
Start Date: UNK/U
NK/197
4
Ongoing: YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130373
Page 209 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Aug-03-2020
15:33:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
15:33:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Latex allergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-03-2020
15:33:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1974Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130374
Page 210 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:33:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-21-2020
11:12:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Line/MH
Number:6
Medical
History T
erm:Dilation an
d curettage
Start Dat
e:May/UNK/
2019
Ongoing: NO
End Date:
May/U
NK/201
9updated
Aug-19-2020
07:53:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:D & CInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130375
Page 211 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Start Date
:May/UNK
/2019
Ongoing: NO
End Date
:
May/U
NK/20
19
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130376
Page 212 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:53:14
(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-24-2020
07:08:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Closed Response
satisfies query
Aug-21-2020
11:12:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered updated
Aug-21-2020
11:12:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Dilation and curett
ageupdated
Aug-21-2020
02:55:58
(UTC-05:00)ACV0PFEINFP6000 Lingyan
Zuo
(pfe.zuol02)Query 1: Opened ClinQuery: D &
C: Please can
you update the
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130377
Page 213 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)verbatim term to
indicate what the
disease/diagnosis
/syndrome is?
Thanks
Aug-19-2020
07:53:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
D & CInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-19-2020
07:53:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
May/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-19-2020
07:53:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
May/UNK/2019Initial Entry
1.g
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130378
Page 214 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-19-2020
07:54:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:Hysterecto
my
Start Date
:Dec/UNK/
2019
Ongoing: NO
End Dat
e:
Dec/U
NK/20
19Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130379
Page 215 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.g Line/MH Number:
Date Location User Value Reason
Aug-19-2020
07:54:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020
07:54:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
HysterectomyInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-19-2020
07:54:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Dec/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130380
Page 216 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-19-2020
07:54:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Dec/UNK/2019Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130381
Page 217 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10071117 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-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
90.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130382
Page 218 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
173.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.2Initial Entry
7.a
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Record Ide 1Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130383
Page 219 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)ntifier::
Temperatur
e:36.7
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130384
Page 220 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-03-2020
15:30:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130385
Page 221 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-21-2020
04:09:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Closed Response
satisfies query
Aug-19-2020
07:54:34ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered updated MH
form
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130386
Page 222 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-18-2020
22:55:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Reissued:
Openedplease check
intermittently
for the form to
be unfrozen as
the form will
not unfreeze if
the query is
with Pfizer
staff. thanks for
your
cooperation.
Aug-17-2020
17:02:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered med history
form is frozen;
will enter when
becomes
available
Aug-16-2020
20:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Reissued:
Openedplease update
Medhx to
capture this
information.
thanks
Aug-13-2020
08:41:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Query 1: Answered subject had
hysterectomy;
will add to
medical history
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130387
Page 223 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-12-2020
20:33:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hui Pan
(pfe.panh18)Query 1: Opened Subject is listed
not to have had
a pregnancy
test, however,
there is nothing
in her medhx to
indicate she is
not a woman of
child bearing
potential.
Please review
and update as
appropriate.
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130388
Page 224 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sponsor-Defi
ned Identifie
r:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130389
Page 225 of 341
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Test:
Date Location User Value Reason
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-03-2020
15:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130390
Page 226 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-03-2020
15:34:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-07-2020
04:37:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Response
satisfies query
Aug-06-2020
09:01:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edChanged
Information
Aug-06-2020
09:01:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
41898Changed
Information
Aug-06-2020 ACV0PFEINFP6000 Amol Query 1: Opened IVRS
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130391
Page 227 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
07:35:10
(UTC-05:00)
Eastern Time
(US & Canada)Deshmukh
(pfe.deshma24)Reconciliation:
Randomization
Number
(41898)
recorded at
impala is not
matching with
number entered
in Inform.
Please review
and update data
as appropriate.
Else, clarify.
Thank you.
Aug-03-2020
15:34:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
418898Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130392
Page 228 of 341
***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: 10071117 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-03-2020
15:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-03-2020
15:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-03-2020
17:22:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-03-2020
15:28:22ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130393
Page 229 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-03-2020
15:28:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
Aug-03-2020
17:22:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89D
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-03-2020
17:22:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89DRInitial Entry
5.b
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130394
Page 230 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-03-2020
17:22:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89D
SInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-03-2020
17:22:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89DSInitial Entry
5.c
Date Location User Value Reason
Aug-03-2020
17:22:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89D
TInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130395
Page 231 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Aug-03-2020
17:22:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89DTInitial Entry
5.d
Date Location User Value Reason
Aug-03-2020
17:23:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BPFZX
LInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-03-2020
17:23:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZXLInitial Entry
5.e
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130396
Page 232 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
17:23:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample I
D:BPFZX
MInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-03-2020
17:23:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BPFZXMInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130397
Page 233 of 341
***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: 10071117 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-03-2020
15:28:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-03-2020
15:28:31
(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-03-2020
17:22:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-03-2020
15:28:31ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130398
Page 234 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-03-2020
15:28:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
Aug-03-2020
17:22:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID
:BM89D
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-03-2020
17:22:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jesse
LePage
(pfe.jlepage)Data Entry:
BM89D8Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130399
Page 235 of 341
***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: 10071117 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-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130400
Page 236 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/3/2020 15:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130401
Page 237 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-03-2020
16:12:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130402
Page 238 of 341
***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: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-04-2020
13:22:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS S
UBJECTInitial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130403
Page 239 of 341
***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: 10071117 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-24-2020
14:52:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Aug/24/2020Initial Entry
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130404
Page 240 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 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-24-2020
14:55:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-24-2020
14:55:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae4029\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130405
Page 241 of 341
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071117 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-24-2020
14:55:16
(UTC-05:
…[truncated]