Document text
Page 1 of 614
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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 version27 MAY 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 1 SENTINEL COHORTS
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129102
Page 2 of 614
***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: 10071050 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
Jun/11/2020
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129103
Page 3 of 614
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071050]
2.Birth Date: /1982
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):ASIAN
6.Racial Designation:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0129104
Page 4 of 614
***Confidential***
Header Text: c4591001
Visit: SCR 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: 10071050 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 Jun/11/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129105
Page 5 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129106
Page 6 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129107
Page 7 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
2.eExclusion Number: 5
Criterion Description: Stages 1 and 2 only: Previous clinical or microbiological
diagnosis of COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX05A00
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129108
Page 8 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.fExclusion Number: 6
Criterion Description: Sentinel participants in Stage 1 only: Individuals at high risk
for severe COVID-19 (full details in protocol)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX06A01
2.gExclusion Number: 7
Criterion Description: Sentinel participants in Stage 1 only: Individuals currently
working in occupations with high risk of exposure to
SARS-CoV-2 (eg, healthcare worker, emergency response
personnel)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX07A00
2.hExclusion 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129109
Page 9 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.iExclusion Number: 9
Criterion Description: Individuals with a history of autoimmune disease or an active
autoimmune disease requiring therapeutic intervention
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX09A00
2.jExclusion 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.kExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
2.lExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129110
Page 10 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.mExclusion 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.nExclusion Number: 14
Criterion Description: Sentinel participants in Stage 1 only: Regular receipt of
inhaled/nebulized corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX22A01
2.oExclusion 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129111
Page 11 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.pExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.qExclusion 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.rExclusion Number: 18
Criterion Description: Sentinel participants in Stage 1 only: Positive serological test
for SARS-CoV-2 IgM and/or IgG antibodies at the screening
visit
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX17A01
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129112
Page 12 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.sExclusion Number: 19
Criterion Description: Sentinel participants in Stage 1 only: Screening
hematology/blood chemistry lab >=Grade 1 abnormality.
Except Bilirubin, other stable Grade1 abnormalities may be
considered eligible by Investigator
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX18A01
2.tExclusion Number: 20
Criterion Description: Sentinel participants in Stage 1 only: Positive test for HIV,
hepatitis B surface antigen (HBsAg), hepatitis B core
antibodies (HBc Abs), or hepatitis C virus antibodies (HCV
Abs) at screening visit
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX19A01
2.uExclusion Number: 21
Criterion Description: Sentinel participants in Stage 1 only: SARS-CoV-2
NAAT-positive nasal swab within 24 hours before receipt of
study intervention
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX20A01
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129113
Page 13 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.vExclusion 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129114
Page 14 of 614
***Confidential***
Header Text: c4591001
Visit: SCR 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: 10071050 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
/DeathJun/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129115
Page 15 of 614
***Confidential***
Header Text: c4591001
Visit: SCR 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: 10071050 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 allergy]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Uterine leiomyoma]
Start Date: Sep/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anemia]
Start Date: Sep/UNK/2019
Ongoing: YES
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129116
Page 16 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE
Form Version: 22-Apr-2020 21:04
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-
Defined I
dentifierCategory for M
edicationConcomitant
Medications
Pre-specifiedName of MedicationDose
Descri
ptionForm Insta
nce
1.1 GENERAL CO
NCOMITANT
MEDICATION
S NO Ethinyl estradiol 20 mic
rogram and norethindro
ne acetate 1 mg oral tabl
et 1/20 Repeating
Pages
2.2 GENERAL CO
NCOMITANT
MEDICATION
S NO Chlorpheniramine male
ate 4 Repeating
Pages
3.3 GENERAL CO
NCOMITANT
MEDICATION
S NO Ferrous fumarate-contai
ning product in oral dos
e form 1 Repeating
Pages
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129117
Page 17 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Ethinyl estradiol 20 microgram and norethindrone acetate 1 mg
oral tablet]
5.Dose: [1/20]
6.Dose Unit: ug
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: UNK/UNK/2010
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129118
Page 18 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[2]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Chlorpheniramine maleate]
5.Dose: [4]
6.Dose Unit: mg
7.Dose Frequency: PRN
8.Route: ORAL
9.Start Date: UNK/UNK/2016
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129119
Page 19 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[3]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Ferrous fumarate-containing product in oral dose
form]
5.Dose: [1]
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Feb/UNK/2020
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129120
Page 20 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jun/11/2020
Physical Examination Result
2.aBody System Examined: GENERAL APPEARANCE
Result: NORMAL
2.bBody System Examined: SKIN
Result: NORMAL
2.cBody System Examined: HEAD
Result: NORMAL
2.dBody System Examined: EYES
Result: NORMAL
2.eBody System Examined: EARS
Result: NORMAL
2.fBody System Examined: NOSE
Result: NORMAL
2.gBody System Examined: THROAT
Result: NORMAL
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129121
Page 21 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.hBody System Examined: HEART
Result: NORMAL
2.iBody System Examined: LUNGS
Result: NORMAL
2.jBody System Examined: ABDOMEN
Result: NORMAL
2.kBody System Examined: MUSCULOSKELETAL
Result: NORMAL
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2.mBody System Examined: NEUROLOGICAL
Result: NORMAL
2.nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129122
Page 22 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: VITAL SIGNS - BASELINE
Form Version: 19-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jun/11/2020
2.Weight: [64.6]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [22.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: ORAL CAVITY
Systolic: [117]
Diastolic: [89]
BP Position: SITTING
Pulse: [79]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129123
Page 23 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: ELECTRONIC SAMPLE TRACKING - PRIOR
COVID-19 INFECTION
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: 10071050 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:
Jun/11/2020
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 [BNBND2]
5.bSample ID [BNBND3]
5.cSample ID [BNY247]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129124
Page 24 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:04
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of
Collectio
nSpecim
en TypeAssay Code and Descriptio
nDevice Type ResultForm Insta
nce
1.Jun/11/2
020 BLOO
D SEVERE ACUTE RESP S
YNDROME CORONAVIR
US 2 SARS-COV-2 DI
AGNOSTIC TES
T NEGA
TIVE Repeating
Pages
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129125
Page 25 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: MICROBIOLOGY SPECIMEN
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jun/11/2020
2.Specimen Type: BLOOD
3.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
4.Device Type: SARS-COV-2 DIAGNOSTIC TEST
5.Test Result: NEGATIVE
6.Comments/Findings
/Details:[ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129126
Page 26 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: CENTRAL LAB SAMPLE COLLECTION -
BASELINE
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jun/11/2020
2.Specimen Type: BLOOD
Lab Test
3.aLab Panel: CLINICAL CHEMISTRY
Lab Sub-Panel: BLOOD CHEMISTRY
Was the lab sub-panel
collected?:YES
3.bLab Panel: CLINICAL CHEMISTRY
Lab Sub-Panel: VIROLOGY
Was the lab sub-panel
collected?:YES
3.cLab Panel: HEMATOLOGY
Lab Sub-Panel: DIFFERENTIAL
Was the lab sub-panel
collected?:YES
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129127
Page 27 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 19-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jun/11/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129128
Page 28 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S 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: 10071050 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 Jun/22/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129129
Page 29 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Physical Examination
1.Exam Date: Not Applicable
//Comments
Physical Examination Result
2.aBody System Examined: GENERAL APPEARANCE
Result: Not Applicable Comments
2.bBody System Examined: SKIN
Result: Not Applicable Comments
2.cBody System Examined: HEAD
Result: Not Applicable Comments
2.dBody System Examined: EYES
Result: Not Applicable Comments
2.eBody System Examined: EARS
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129130
Page 30 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.fBody System Examined: NOSE
Result: Not Applicable Comments
2.gBody System Examined: THROAT
Result: Not Applicable Comments
2.hBody System Examined: HEART
Result: Not Applicable Comments
2.iBody System Examined: LUNGS
Result: Not Applicable Comments
2.jBody System Examined: ABDOMEN
Result: Not Applicable Comments
2.kBody System Examined: MUSCULOSKELETAL
Result: Not Applicable Comments
2.lBody System Examined: EXTREMITIES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129131
Page 31 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.mBody System Examined: NEUROLOGICAL
Result: Not Applicable Comments
2.nBody System Examined: LYMPH NODES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129132
Page 32 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: VITAL SIGNS
Form Version: 19-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jun/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
Systolic: [119]
Diastolic: [72]
BP Position: SITTING
Pulse: [68]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129133
Page 33 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 19-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jun/22/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129134
Page 34 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S 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: 10071050 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:
Jun/22/2020
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 [BNBSW4]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129135
Page 35 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:05
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Jun/22/
2020 SWABBE
D MATER
IAL NASAL CA
VITY SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129136
Page 36 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jun/22/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASAL CAVITY
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129137
Page 37 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Jun/22/2020
2.Randomization Number: [2300]
3.Randomization Group: [Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day
(BNT162b2 or PBO)]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129138
Page 38 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: STRATIFICATION
Form Version: 12-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Stratification
1.Select appropriate response
- Randomization StageStage 1
2.Select appropriate response
- Randomization Age
GroupAge 18 to 55
3.Select appropriate response
- Randomization DoseMedium dose level (30mcg)
4.Select appropriate response
- Randomization Dose
Group21 Day
5.Select appropriate response
- BNT Number(BNT162b2 or PBO)
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129139
Page 39 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S 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: 10071050 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:
Jun/22/2020
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 [BNBSWC]
5.bSample ID [BNBSWD]
5.cSample ID [BNBSWF]
5.dSample ID [BNBSWG]
5.eSample ID [BNBSWH]
5.fSample ID [BNY28N]
5.gSample ID [BNY28P]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129140
Page 40 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.hSample ID [BNY28R]
5.iSample ID [BNY28S]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129141
Page 41 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S 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: 10071050 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: Jun/22/2020 11:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [0.5]
9.Unit: mL
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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129142
Page 42 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S 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: 10071050 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 Jun/24/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129143
Page 43 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Physical Examination
1.Exam Date: Not Applicable
//Comments
Physical Examination Result
2.aBody System Examined: GENERAL APPEARANCE
Result: Not Applicable Comments
2.bBody System Examined: SKIN
Result: Not Applicable Comments
2.cBody System Examined: HEAD
Result: Not Applicable Comments
2.dBody System Examined: EYES
Result: Not Applicable Comments
2.eBody System Examined: EARS
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129144
Page 44 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.fBody System Examined: NOSE
Result: Not Applicable Comments
2.gBody System Examined: THROAT
Result: Not Applicable Comments
2.hBody System Examined: HEART
Result: Not Applicable Comments
2.iBody System Examined: LUNGS
Result: Not Applicable Comments
2.jBody System Examined: ABDOMEN
Result: Not Applicable Comments
2.kBody System Examined: MUSCULOSKELETAL
Result: Not Applicable Comments
2.lBody System Examined: EXTREMITIES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129145
Page 45 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.mBody System Examined: NEUROLOGICAL
Result: Not Applicable Comments
2.nBody System Examined: LYMPH NODES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129146
Page 46 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: VITAL SIGNS
Form Version: 19-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jun/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
Systolic: [110]
Diastolic: [83]
BP Position: SITTING
Pulse: [90]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129147
Page 47 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: CENTRAL LAB SAMPLE COLLECTION
Form Version: 19-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jun/24/2020
2.Specimen Type: BLOOD
Lab Test
3.aLab Panel: CLINICAL CHEMISTRY
Lab Sub-Panel: BLOOD CHEMISTRY
Was the lab sub-panel
collected?:YES
3.bLab Panel: HEMATOLOGY
Lab Sub-Panel: DIFFERENTIAL
Was the lab sub-panel
collected?:YES
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129148
Page 48 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S 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: 10071050 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 Jun/29/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129149
Page 49 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Physical Examination
1.Exam Date: Not Applicable
//Comments
Physical Examination Result
2.aBody System Examined: GENERAL APPEARANCE
Result: Not Applicable Comments
2.bBody System Examined: SKIN
Result: Not Applicable Comments
2.cBody System Examined: HEAD
Result: Not Applicable Comments
2.dBody System Examined: EYES
Result: Not Applicable Comments
2.eBody System Examined: EARS
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129150
Page 50 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.fBody System Examined: NOSE
Result: Not Applicable Comments
2.gBody System Examined: THROAT
Result: Not Applicable Comments
2.hBody System Examined: HEART
Result: Not Applicable Comments
2.iBody System Examined: LUNGS
Result: Not Applicable Comments
2.jBody System Examined: ABDOMEN
Result: Not Applicable Comments
2.kBody System Examined: MUSCULOSKELETAL
Result: Not Applicable Comments
2.lBody System Examined: EXTREMITIES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129151
Page 51 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.mBody System Examined: NEUROLOGICAL
Result: Not Applicable Comments
2.nBody System Examined: LYMPH NODES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129152
Page 52 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: VITAL SIGNS
Form Version: 19-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jun/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
Systolic: [134]
Diastolic: [71]
BP Position: SITTING
Pulse: [80]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129153
Page 53 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: CENTRAL LAB SAMPLE COLLECTION
Form Version: 19-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jun/29/2020
2.Specimen Type: BLOOD
Lab Test
3.aLab Panel: CLINICAL CHEMISTRY
Lab Sub-Panel: BLOOD CHEMISTRY
Was the lab sub-panel
collected?:YES
3.bLab Panel: HEMATOLOGY
Lab Sub-Panel: DIFFERENTIAL
Was the lab sub-panel
collected?:YES
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129154
Page 54 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S 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: 10071050 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:
Jun/29/2020
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 [BNBT2P]
5.bSample ID [BNBT2R]
5.cSample ID [BNBT2S]
5.dSample ID [BNBT2T]
5.eSample ID [BNBT2V]
5.fSample ID [BNY2FB]
5.gSample ID [BNY2FC]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129155
Page 55 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.hSample ID [BNY2FD]
5.iSample ID [BNY2FF]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129156
Page 56 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/13/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129157
Page 57 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129158
Page 58 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129159
Page 59 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129160
Page 60 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Physical Examination
1.Exam Date: Not Applicable
//Comments
Physical Examination Result
2.aBody System Examined: GENERAL APPEARANCE
Result: Not Applicable Comments
2.bBody System Examined: SKIN
Result: Not Applicable Comments
2.cBody System Examined: HEAD
Result: Not Applicable Comments
2.dBody System Examined: EYES
Result: Not Applicable Comments
2.eBody System Examined: EARS
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129161
Page 61 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.fBody System Examined: NOSE
Result: Not Applicable Comments
2.gBody System Examined: THROAT
Result: Not Applicable Comments
2.hBody System Examined: HEART
Result: Not Applicable Comments
2.iBody System Examined: LUNGS
Result: Not Applicable Comments
2.jBody System Examined: ABDOMEN
Result: Not Applicable Comments
2.kBody System Examined: MUSCULOSKELETAL
Result: Not Applicable Comments
2.lBody System Examined: EXTREMITIES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129162
Page 62 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.mBody System Examined: NEUROLOGICAL
Result: Not Applicable Comments
2.nBody System Examined: LYMPH NODES
Result: Not Applicable Comments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129163
Page 63 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: VITAL SIGNS
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jul/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
Systolic: [119]
Diastolic: [77]
BP Position: SITTING
Pulse: [75]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129164
Page 64 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 19-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/13/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129165
Page 65 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/13/2020
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 [BNBTD8]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129166
Page 66 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:05
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Jul/13/2
020 SWABBE
D MATER
IAL NASAL CA
VITY SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129167
Page 67 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jul/13/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASAL CAVITY
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129168
Page 68 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: CENTRAL LAB SAMPLE COLLECTION
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jul/13/2020
2.Specimen Type: BLOOD
Lab Test
3.aLab Panel: CLINICAL CHEMISTRY
Lab Sub-Panel: BLOOD CHEMISTRY
Was the lab sub-panel
collected?:YES
3.bLab Panel: HEMATOLOGY
Lab Sub-Panel: DIFFERENTIAL
Was the lab sub-panel
collected?:YES
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129169
Page 69 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/13/2020
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 [BNBTFG]
5.bSample ID [BNBTFH]
5.cSample ID [BNBTFJ]
5.dSample ID [BNBTFK]
5.eSample ID [BNBTFL]
5.fSample ID [BNY2PG]
5.gSample ID [BNY2PH]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129170
Page 70 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.hSample ID [BNY2PJ]
5.iSample ID [BNY2PK]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129171
Page 71 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jul/13/2020 15:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [0.5]
9.Unit: mL
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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129172
Page 72 of 614
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/16/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129173
Page 73 of 614
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S Form: PHYSICAL EXAMINATION
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/16/2020
Physical Examination Result
2.aBody System Examined: GENERAL APPEARANCE
Result: NOT DONE
2.bBody System Examined: SKIN
Result: NOT DONE
2.cBody System Examined: HEAD
Result: NOT DONE
2.dBody System Examined: EYES
Result: NOT DONE
2.eBody System Examined: EARS
Result: NOT DONE
2.fBody System Examined: NOSE
Result: NOT DONE
2.gBody System Examined: THROAT
Result: NOT DONE
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129174
Page 74 of 614
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S Form: PHYSICAL EXAMINATION
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.hBody System Examined: HEART
Result: NOT DONE
2.iBody System Examined: LUNGS
Result: NOT DONE
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2.kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
2.lBody System Examined: EXTREMITIES
Result: NOT DONE
2.mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2.nBody System Examined: LYMPH NODES
Result: ABNORMAL
If abnormal findings, specify: (If clinically significant,
record on the Medical History or Adverse Event CRF as
appropriate).
[has 1x2 cm non-tender, mobile node in right axillae]
Are there clinically significant findings?
YES
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129175
Page 75 of 614
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S Form: VITAL SIGNS
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jul/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
Systolic: [124]
Diastolic: [81]
BP Position: SITTING
Pulse: [70]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129176
Page 76 of 614
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S Form: CENTRAL LAB SAMPLE COLLECTION
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jul/16/2020
2.Specimen Type: BLOOD
Lab Test
3.aLab Panel: CLINICAL CHEMISTRY
Lab Sub-Panel: BLOOD CHEMISTRY
Was the lab sub-panel
collected?:YES
3.bLab Panel: HEMATOLOGY
Lab Sub-Panel: DIFFERENTIAL
Was the lab sub-panel
collected?:YES
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129177
Page 77 of 614
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/16/2020
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 [BP74PH]
5.bSample ID [BP74PJ]
5.cSample ID [BP74PK]
5.dSample ID [BP74PL]
5.eSample ID [BP74PM]
5.fSample ID [BNY2VL]
5.gSample ID [BNY2VM]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129178
Page 78 of 614
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.hSample ID [BNY2VN]
5.iSample ID [BNY2VP]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129179
Page 79 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/27/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129180
Page 80 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129181
Page 81 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129182
Page 82 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129183
Page 83 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S Form: PHYSICAL EXAMINATION
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/27/2020
Physical Examination Result
2.aBody System Examined: GENERAL APPEARANCE
Result: NOT DONE
2.bBody System Examined: SKIN
Result: NOT DONE
2.cBody System Examined: HEAD
Result: NOT DONE
2.dBody System Examined: EYES
Result: NOT DONE
2.eBody System Examined: EARS
Result: NOT DONE
2.fBody System Examined: NOSE
Result: NOT DONE
2.gBody System Examined: THROAT
Result: NOT DONE
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129184
Page 84 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S Form: PHYSICAL EXAMINATION
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.hBody System Examined: HEART
Result: NOT DONE
2.iBody System Examined: LUNGS
Result: NOT DONE
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2.kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
2.lBody System Examined: EXTREMITIES
Result: NOT DONE
2.mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2.nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129185
Page 85 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S Form: VITAL SIGNS
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Jul/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
Systolic: [137]
Diastolic: [83]
BP Position: SITTING
Pulse: [78]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129186
Page 86 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/27/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP74YL]
5.bSample ID [BP74YM]
5.cSample ID [BP74YN]
5.dSample ID [BP74YP]
5.eSample ID [BP74YR]
5.fSample ID [BNY31Y]
5.gSample ID [BNY31Z]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129187
Page 87 of 614
***Confidential***
Header Text: c4591001
Visit: V6_WEEK2_POSTVAX2_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.hSample ID [BNY320]
5.iSample ID [BNY321]
5.jSample ID [BNY322]
5.kSample ID [BNY323]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129188
Page 88 of 614
***Confidential***
Header Text: c4591001
Visit: V7_MONTH1_S 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: 10071050 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/10/2020
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129189
Page 89 of 614
***Confidential***
Header Text: c4591001
Visit: V7_MONTH1_S 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: 10071050 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/10/2020
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 [BM811Z]
5.bSample ID [BM8120]
5.cSample ID [BM8121]
5.dSample ID [BM8122]
5.eSample ID [BM8123]
5.fSample ID [BPG03B]
5.gSample ID [BPG03C]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129190
Page 90 of 614
***Confidential***
Header Text: c4591001
Visit: V7_MONTH1_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.hSample ID [BPG03D]
5.iSample ID [BPG03F]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129191
Page 91 of 614
***Confidential***
Header Text: c4591001
Visit: V8_MONTH6_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129192
Page 92 of 614
***Confidential***
Header Text: c4591001
Visit: V8_MONTH6_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BR3YDD]
5.bSample ID [BMNR6L]
5.cSample ID [BMNR6S]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129193
Page 93 of 614
***Confidential***
Header Text: c4591001
Visit: V9_MONTH12_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129194
Page 94 of 614
***Confidential***
Header Text: c4591001
Visit: V9_MONTH12_S Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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 [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129195
Page 95 of 614
***Confidential***
Header Text: c4591001
Visit: V10_MONTH24_S 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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129196
Page 96 of 614
***Confidential***
Header Text: c4591001
Visit: V10_MONTH24_S Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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 [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129197
Page 97 of 614
***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: 10071050 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:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129198
Page 98 of 614
***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: 10071050 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: [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129199
Page 99 of 614
***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: 10071050 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 [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129200
Page 100 of 614
***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: 10071050 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 [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129201
Page 101 of 614
***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: 10071050 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?
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129202
Page 102 of 614
***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: 10071050 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:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129203
Page 103 of 614
***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: 10071050 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:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129204
Page 104 of 614
***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: 10071050 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 [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129205
Page 105 of 614
***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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129206
Page 106 of 614
***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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129207
Page 107 of 614
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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 :Aug/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129208
Page 108 of 614
***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: 10071050 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: [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129209
Page 109 of 614
***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: 10071050 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:
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129210
Page 110 of 614
***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: 10071050 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 [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129211
Page 111 of 614
***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: 10071050 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 Right axillary lymp
h node enlargement
Jul/15/2020
UNK:UNK NO
End Date Time:
Jul/27/2020 UN
K:UNK
Repeating
Pages
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FDA-CBER-2021-5683-0129212
Page 112 of 614
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Right axillary lymph node enlargement]
4.Start Date Time: Jul/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jul/27/2020 UNK:UNK
6.Toxicity Grade: 1
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
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Page 114 of 614
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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[ ]
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FDA-CBER-2021-5683-0129215
Page 115 of 614
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 22-Apr-2020 21:04
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
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FDA-CBER-2021-5683-0129216
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
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: 10071050 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[ ]
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FDA-CBER-2021-5683-0129217
Page 117 of 614
***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: 10071050 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
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FDA-CBER-2021-5683-0129218
Page 118 of 614
***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: 10071050 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: //
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***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: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129220
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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?
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Page 121 of 614
***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: 10071050 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
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FDA-CBER-2021-5683-0129222
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***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: 10071050 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?
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129223
FDA-CBER-2021-5683-0129224
Page 124 of 614
***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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
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***Confidential***
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital
Medical Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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FDA-CBER-2021-5683-0129226
Page 126 of 614
***Confidential***
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital
Medical Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
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FDA-CBER-2021-5683-0129227
Page 127 of 614
***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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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FDA-CBER-2021-5683-0129228
Page 128 of 614
***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: 10071050 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:
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Page 129 of 614
***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: 10071050 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:
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***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: 10071050 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?
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FDA-CBER-2021-5683-0129231
Page 131 of 614
***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: 10071050 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: [ ]
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FDA-CBER-2021-5683-0129232
Page 132 of 614
***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: 10071050 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: [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129233
Page 133 of 614
***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: 10071050 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/28/2020
2.Erroneous Visit
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FDA-CBER-2021-5683-0129234
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***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
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FDA-CBER-2021-5683-0129235
Page 135 of 614
***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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
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FDA-CBER-2021-5683-0129236
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***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
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FDA-CBER-2021-5683-0129237
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***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: 10071050 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: [ ]
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129238
Page 138 of 614
***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: 10071050 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 Aug/10/2020
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129239
Page 139 of 614
***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: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129240
Page 140 of 614
***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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Frenck Approved Mar-07-2021 21:07:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
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FDA-CBER-2021-5683-0129241
Page 141 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE -
Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Jun-22-2020 11:49:04 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129242
Page 142 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129243
Page 143 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Jun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129244
Page 144 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.aJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129245
Page 145 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.bJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129246
Page 146 of 614
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.cJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.dJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 148 of 614
***Confidential***
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.eJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 149 of 614
***Confidential***
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.fJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 150 of 614
***Confidential***
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.gJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.hJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.iJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.jJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.kJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.lJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 156 of 614
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Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.mJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.nJun-22-2020 11:50:00 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Jun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 160 of 614
***Confidential***
Header Text: c4591001
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.aJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.bJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 162 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.cJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 163 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.dJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129264
Page 164 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.eJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 165 of 614
***Confidential***
Header Text: c4591001
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.fJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129266
Page 166 of 614
***Confidential***
Header Text: c4591001
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.gJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 167 of 614
***Confidential***
Header Text: c4591001
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Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.hJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129268
Page 168 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.iJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129269
Page 169 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.jJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 170 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.kJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 171 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.lJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 172 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.mJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 173 of 614
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.nJun-24-2020 13:50:03 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129274
Page 174 of 614
***Confidential***
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Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
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Page 175 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Jun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129276
Page 176 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.aJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129277
Page 177 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.bJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129278
Page 178 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.cJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129279
Page 179 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.dJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129280
Page 180 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.eJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129281
Page 181 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.fJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129282
Page 182 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.gJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129283
Page 183 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.hJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129284
Page 184 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.iJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129285
Page 185 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.jJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129286
Page 186 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.kJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129287
Page 187 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.lJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129288
Page 188 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.mJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129289
Page 189 of 614
***Confidential***
Header Text: c4591001
Visit: V3_WEEK1_POSTVAX1_S Form: PHYSICAL EXAMINATION - Comments
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.nJun-29-2020 13:26:30 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129290
Page 190 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129291
Page 191 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Jul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129292
Page 192 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.aJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129293
Page 193 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.bJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129294
Page 194 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.cJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129295
Page 195 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.dJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129296
Page 196 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.eJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129297
Page 197 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.fJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129298
Page 198 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.gJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129299
Page 199 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.hJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129300
Page 200 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.iJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129301
Page 201 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.jJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129302
Page 202 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.kJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129303
Page 203 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.lJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129304
Page 204 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.mJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129305
Page 205 of 614
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: PHYSICAL EXAMINATION - Comments
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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2.nJul-13-2020 14:24:31 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129306
Page 206 of 614
***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: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Frenck Approved Mar-07-2021 21:07:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFrenck, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Laura Pace N/A Feb-16-2021 16:06:27 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Jan-11-2021 15:47:30 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129307
Page 207 of 614
***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: 10071050 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 Jan-04-2021 10:20:41 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Aug-12-2020 14:52:55 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129308
Page 208 of 614
***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: 10071050 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.
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129309
Page 209 of 614
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
Jun-11-2020
15:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
27 MAY 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jun-11-2020
15:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
STAGE 1 SENTINEL
COHORTSInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129310
Page 210 of 614
***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: 10071050 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
Jun-11-2020
15:07:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent
Obtained
Jun/11/2020Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129311
Page 211 of 614
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
Jun-11-2020
15:06:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10071050Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jun-22-2020
11:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
/1982Changed
Information
Jun-11-2020
15:06:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1982Screening Log
Entry
3. Sex:
Date Location User Value Reason
Jun-11-2020
15:07:28
(UTC-05:00)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0129312
Page 212 of 614
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Eastern Time (US
& Canada)
4. Ethnicity:
Date Location User Value Reason
Jun-11-2020
15:07:28
(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
Jun-11-2020
15:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
ASIANInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129313
Page 213 of 614
***Confidential***
Header Text: c4591001
Visit: SCR 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: 10071050 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
Jun-11-2020
15:07:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Jun/11/2020Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129314
Page 214 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129315
Page 215 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129316
Page 216 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.a Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Incl
usio
n Nu
mbe
r:2Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129317
Page 217 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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 on
ly):IN02A00
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129318
Page 218 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Inclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129319
Page 219 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129320
Page 220 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129321
Page 221 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Inclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129322
Page 222 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jun-22-2020
11:38:28
(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 sign
ed informed con
sent, which incl
udes complianc
e with the requi
rements and rest
rictions listed in
the ICD and in t
his protocol
Crit
erio
n me
t?:YESInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129323
Page 223 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129324
Page 224 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Inclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129325
Page 225 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129326
Page 226 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129327
Page 227 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.a Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129328
Page 228 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129329
Page 229 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.b Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129330
Page 230 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129331
Page 231 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129332
Page 232 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.c Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129333
Page 233 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129334
Page 234 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.d Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129335
Page 235 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclus
ion Nu
mber:5
Criteri
on Des
criptio
n:Stages 1 and
2 only: Previo
us clinical or
microbiologic
al diagnosis o
f COVID-19
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX05A00Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129336
Page 236 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.e Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
5Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Stages 1 and 2 only: Pr
evious clinical or micr
obiological diagnosis o
f COVID-19Initial Entry
2.e Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129337
Page 237 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX05A00Initial Entry
2.f
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion
Num
ber:6
Crite
rion
Descr
iption
:Sentinel partici
pants in Stage
1 only: Individ
uals at high ris
k for severe C
OVID-19 (full
details in proto
col)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX06A01Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129338
Page 238 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
6Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sentinel participants in
Stage 1 only: Individu
als at high risk for seve
re COVID-19 (full det
ails in protocol)Initial Entry
2.f Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129339
Page 239 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX06A01Initial Entry
2.g
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Excl
usio
n N
umb
er:7
Crit
erio
n De
scri
ptio
n:Sentinel particip
ants in Stage 1 o
nly: Individuals
currently workin
g in occupations
with high risk of
exposure to SA
RS-CoV-2 (eg, h
ealthcare worker
, emergency res
ponse personnel
)
Crit
erio
n m
et?:NOInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129340
Page 240 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX07A00
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129341
Page 241 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.g Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
7Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sentinel participants in
Stage 1 only: Individu
als currently working i
n occupations with hig
h risk of exposure to S
ARS-CoV-2 (eg, healt
hcare worker, emergen
cy response personnel)Initial Entry
2.g Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129342
Page 242 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX07A00Initial Entry
2.h
Date Location User Value Reason
Jun-22-2020
11:38:28
(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/ph
ysical examinat
ion
Crite
rion
met?
:NOInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129343
Page 243 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crite
rion
ID: (
For
Pfize
r use
only)
:EX08A00
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129344
Page 244 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
8Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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.h Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129345
Page 245 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX08A00Initial Entry
2.i
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion
Num
ber:9
Crite
rion
Descr
iption
:Individuals wit
h a history of a
utoimmune dis
ease or an activ
e autoimmune
disease requiri
ng therapeutic
intervention
Crite
rion
met?:NOInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129346
Page 246 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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):EX09A00
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129347
Page 247 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.i Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
9Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Individuals with a hist
ory of autoimmune dis
ease or an active autoi
mmune disease requiri
ng therapeutic interven
tionInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129348
Page 248 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX09A00Initial Entry
2.j
Date Location User Value Reason
Jun-22-2020
11:38:28
(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 in
jection
Crit
erio
n me
t?:NOInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129349
Page 249 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129350
Page 250 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.j Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
10Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(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.j Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129351
Page 251 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX10A00Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129352
Page 252 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
2.k
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclusio
n Numbe
r:11
Criterion
Descripti
on:Women w
ho are preg
nant or bre
astfeeding
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX11A00Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129353
Page 253 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.k Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
11Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Women who are pregn
ant or breastfeedingInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129354
Page 254 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX11A00Initial Entry
2.l
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129355
Page 255 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.l Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
12Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(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
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129356
Page 256 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX12A00Initial Entry
2.m
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NOInitial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129357
Page 257 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129358
Page 258 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.m Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
13Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Subjects who receive i
mmunosuppressive th
erapy, such as cytotoxi
c agents or systemic c
orticosteroidsInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129359
Page 259 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
EX13A01Initial Entry
2.n
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Exclus
ion N
umber
:14
Criter
ion De
scripti
on:Sentinel parti
cipants in Sta
ge 1 only: Re
gular receipt
of inhaled/ne
bulized cortic
osteroids
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX22A01Initial Entry
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129360
Page 260 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071050 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.n Exclusion Number:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
14Initial Entry
2.n Criterion Description:
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
Sentinel participants i
n Stage 1 only: Regula
r receipt of inhaled/ne
bulized corticosteroidsInitial Entry
2.n Criterion met?
Date Location User Value Reason
Jun-22-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.n Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae402a\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0129361
Page 261 of 614
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnat
…[truncated]