Document text
Page 1 of 457
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 version13 MAY 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 1 SENTINEL COHORTS
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040840
Page 2 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jun/5/2020
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040841
Page 3 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031038]
2.Birth Date: /1967
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0040842
Page 4 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/5/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040843
Page 5 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years,
inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at
randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled
visits, vaccination plan, laboratory tests, lifestyle considerations, and
other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040844
Page 6 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040845
Page 7 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040846
Page 8 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040847
Page 9 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040848
Page 10 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040849
Page 11 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040850
Page 12 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJun/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040851
Page 13 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Elevated Cholesterol]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Lower Back Pain]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Groin Pain]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040852
Page 14 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia Surgery]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy]
Start Date: UNK/UNK/1972
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hernia Injury]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040853
Page 15 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE
Form Version: 22-Apr-2020 21:04
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Applic
able Repeating
Pages
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040854
Page 16 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040855
Page 17 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION
Form Version: 06-Jun-2020 00:46 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jun/5/2020
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
2.hBody System Examined: HEART
Result: NORMAL
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040856
Page 18 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION
Form Version: 06-Jun-2020 00:46 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040857
Page 19 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: VITAL SIGNS - BASELINE
Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jun/5/2020
2.Weight: [169.0]
3.Unit: LB
4.Height: [69.5]
5.Unit: in
6.Body Mass Index: [24.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
Systolic: [138]
Diastolic: [88]
BP Position: SITTING
Pulse: [64]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040858
Page 20 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jun/5/2020
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 [BNBTN1]
5.bSample ID [BNBTN2]
5.cSample ID [BNYG0J]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040859
Page 21 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:04
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of C
ollectionSpecime
n TypeAssay Code and Description Device Type ResultForm Instan
ce
1.Jun/5/2020
BLOOD SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST NEGA
TIVE Repeating
Pages
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040860
Page 22 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jun/5/2020
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: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040861
Page 23 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: CENTRAL LAB SAMPLE COLLECTION - BASELINE
Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jun/5/2020
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040862
Page 24 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/17/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040863
Page 25 of 457
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION
Form Version: 12-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jun/17/2020
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: NOT DONE
2.fBody System Examined: NOSE
Result: NOT DONE
2.gBody System Examined: THROAT
Result: NOT DONE
2.hBody System Examined: HEART
Result: NOT DONE
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040864
Page 26 of 457
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION
Form Version: 12-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: NOT DONE
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040865
Page 27 of 457
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: VITAL SIGNS
Form Version: 12-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jun/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.9]
Unit: F
Temperature Location: FOREHEAD
Systolic: [143]
Diastolic: [85]
BP Position: SITTING
Pulse: [57]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040866
Page 28 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/17/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNBTXF]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040867
Page 29 of 457
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:05
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descripti
onDevice TypeForm Insta
nce
1.Jun/17/2
020 SWABBED
MATERIAL
NASAL CAVI
TY SEVERE ACUTE RESP S
YNDROME CORONAVIR
US 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040868
Page 30 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jun/17/2020
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: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040869
Page 31 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Jun/17/2020
2.Randomization Number: [2574]
3.Randomization Group: [Stage 1, Age 18 to 55, Low-Mid dose level (20mcg), 21 Day
(BNT162b2 or PBO)]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040870
Page 32 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 DoseLow-Mid dose level (20mcg)
4.Select appropriate response -
Randomization Dose Group21 Day
5.Select appropriate response -
BNT Number(BNT162b2 or PBO)
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040871
Page 33 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jun/17/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNBTW1]
5.bSample ID [BNBTW2]
5.cSample ID [BNBTW3]
5.dSample ID [BNBTW4]
5.eSample ID [BNBTW5]
5.fSample ID [BNYG48]
5.gSample ID [BNYG49]
5.hSample ID [BNYG4B]
5.iSample ID [BNYG4C]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040872
Page 34 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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/17/2020 11:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040873
Page 35 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/19/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040874
Page 36 of 457
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 12-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jun/19/2020
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: NOT DONE
2.fBody System Examined: NOSE
Result: NOT DONE
2.gBody System Examined: THROAT
Result: NOT DONE
2.hBody System Examined: HEART
Result: NOT DONE
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040875
Page 37 of 457
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 12-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: NORMAL
2.mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2.nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040876
Page 38 of 457
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: VITAL SIGNS
Form Version: 12-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jun/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
Systolic: [148]
Diastolic: [76]
BP Position: SITTING
Pulse: [60]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040877
Page 39 of 457
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: CENTRAL LAB SAMPLE COLLECTION
Form Version: 12-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jun/19/2020
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040878
Page 40 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/24/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040879
Page 41 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jun/24/2020
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: 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
2.hBody System Examined: HEART
Result: NOT DONE
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040880
Page 42 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: NORMAL
2.mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2.nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040881
Page 43 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jun/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: FOREHEAD
Systolic: [133]
Diastolic: [76]
BP Position: SITTING
Pulse: [68]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040882
Page 44 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040883
Page 45 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jun/24/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8F8D]
5.bSample ID [BN8F8F]
5.cSample ID [BN8F8G]
5.dSample ID [BN8F8H]
5.eSample ID [BN8F8J]
5.fSample ID [BNYFLN]
5.gSample ID [BNYFLP]
5.hSample ID [BNYFLR]
5.iSample ID [BNYFLS]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040884
Page 46 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/8/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040885
Page 47 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040886
Page 48 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040887
Page 49 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040888
Page 50 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/8/2020
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: NOT DONE
2.fBody System Examined: NOSE
Result: NORMAL
2.gBody System Examined: THROAT
Result: NORMAL
2.hBody System Examined: HEART
Result: NORMAL
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040889
Page 51 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.iBody System Examined: LUNGS
Result: NORMAL
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2.kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2.mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2.nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040890
Page 52 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
Systolic: [149]
Diastolic: [82]
BP Position: SITTING
Pulse: [68]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040891
Page 53 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jul/8/2020
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 [BN8D64]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040892
Page 54 of 457
***Confidential***
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: MICROBIOLOGY SPECIMEN
Form Version: 22-Apr-2020 21:05
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descripti
onDevice TypeForm Insta
nce
1.Jul/8/202
0 SWABBED
MATERIAL
NASAL CAVI
TY SEVERE ACUTE RESP S
YNDROME CORONAVIR
US 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040893
Page 55 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jul/8/2020
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: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040894
Page 56 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jul/8/2020
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040895
Page 57 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/8/2020
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 [BN8D59]
5.bSample ID [BN8D5B]
5.cSample ID [BN8D5C]
5.dSample ID [BN8D5D]
5.eSample ID [BN8D5F]
5.fSample ID [BNYFVC]
5.gSample ID [BNYFVD]
5.hSample ID [BNYFVF]
5.iSample ID [BNYFVG]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040896
Page 58 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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/8/2020 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040897
Page 59 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/14/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040898
Page 60 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/14/2020
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: NOT DONE
2.fBody System Examined: NOSE
Result: NOT DONE
2.gBody System Examined: THROAT
Result: NOT DONE
2.hBody System Examined: HEART
Result: NOT DONE
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040899
Page 61 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.iBody System Examined: LUNGS
Result: NORMAL
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2.kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2.mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2.nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040900
Page 62 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
Systolic: [142]
Diastolic: [86]
BP Position: SITTING
Pulse: [59]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040901
Page 63 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Central Lab Sample Collection
1.Collection Date: Jul/14/2020
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040902
Page 64 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/14/2020
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 [BN8DBH]
5.bSample ID [BN8DBJ]
5.cSample ID [BN8DBK]
5.dSample ID [BN8DBL]
5.eSample ID [BN8DBM]
5.fSample ID [BNYFZ3]
5.gSample ID [BNYFZ4]
5.hSample ID [BNYFZ5]
5.iSample ID [BNYFZ6]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040903
Page 65 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/20/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040904
Page 66 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040905
Page 67 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040906
Page 68 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040907
Page 69 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/20/2020
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: NOT DONE
2.fBody System Examined: NOSE
Result: NOT DONE
2.gBody System Examined: THROAT
Result: NOT DONE
2.hBody System Examined: HEART
Result: NOT DONE
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040908
Page 70 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: NORMAL
2.mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2.nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040909
Page 71 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
Systolic: [153]
Diastolic: [87]
BP Position: SITTING
Pulse: [58]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040910
Page 72 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jul/20/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGJG3T]
5.bSample ID [BGJG3V]
5.cSample ID [BGJG3W]
5.dSample ID [BGJG3X]
5.eSample ID [BGJG3Y]
5.fSample ID [BNYFD7]
5.gSample ID [BNYFD8]
5.hSample ID [BNYFDC]
5.iSample ID [BNYFDD]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040911
Page 73 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040912
Page 74 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BP578L]
5.bSample ID [BP578M]
5.cSample ID [BP578N]
5.dSample ID [BP578P]
5.eSample ID [BP578R]
5.fSample ID [BKDZ3F]
5.gSample ID [BKDZ3G]
5.hSample ID [BKDZ3H]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040913
Page 75 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040914
Page 76 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/30/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLF9]
5.bSample ID [BNWKPP]
5.cSample ID [BNWKPR]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040915
Page 77 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040916
Page 78 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: INFORMED CONSENT - BOOSTER
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Booster
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040917
Page 79 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - BOOSTER
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040918
Page 80 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: DISPOSITION - SCREENING FOR BOOSTER DOSE
Form Version: 20-Feb-2021 02:10 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Booster Dose
1.Date of
Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 2
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040919
Page 81 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Feb/25/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040920
Page 82 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BPYLS3]
5.bSample ID [BVR34V]
5.cSample ID [BVR34W]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040921
Page 83 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BPYLRX]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040922
Page 84 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040923
Page 85 of 457
***Confidential***
Header Text: c4591001
Visit: V8B_WEEK1_POSTVAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040924
Page 86 of 457
***Confidential***
Header Text: c4591001
Visit: V8B_WEEK1_POSTVAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/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 [BPYLV6]
5.bSample ID [BVR37Z]
5.cSample ID [BVR380]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040925
Page 87 of 457
***Confidential***
Header Text: c4591001
Visit: V8C_MONTH1_POSTVAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040926
Page 88 of 457
***Confidential***
Header Text: c4591001
Visit: V8C_MONTH1_POSTVAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040927
Page 89 of 457
***Confidential***
Header Text: c4591001
Visit: V8C_MONTH1_POSTVAX3 Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 20-Feb-2021 02:24 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was
completed?
2.Symptom:
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the
Subject Diary was completed?
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040928
Page 90 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040929
Page 91 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040930
Page 92 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040931
Page 93 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040932
Page 94 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040933
Page 95 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040934
Page 96 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040935
Page 97 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040936
Page 98 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040937
Page 99 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040938
Page 100 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040939
Page 101 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040940
Page 102 of 457
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040941
Page 103 of 457
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040942
Page 104 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Aug/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040943
Page 105 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040944
Page 106 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040945
Page 107 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040946
Page 108 of 457
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identi
fierAdverse E
ventStart DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 appendiciti
s Sep/19/2020 UN
K:UNK NO
End Date Time:
Sep/23/2020 UNK:UN
K
Repeating
Pages
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Page 109 of 457
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[appendicitis]
4.Start Date Time: Sep/19/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/23/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly
or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
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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, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[appendicitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES Comments
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2021001152]
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***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 22-Apr-2020 21:04
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categ
oryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
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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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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-2021-5683-0040951
Page 113 of 457
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040952
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***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040954
Page 116 of 457
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 117 of 457
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
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FDA-CBER-2021-5683-0040956
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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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040957
FDA-CBER-2021-5683-0040958
Page 120 of 457
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
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***Confidential***
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Booster Dose Trigger Form
1.Select appropriate response -
Will the participant return for
consent/eligibility assessment
for the booster dose visit?The participant will return for consent/eligibility assessment for the
booster dose visit
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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Page 124 of 457
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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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Page 126 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
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Page 127 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040966
Page 128 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
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FDA-CBER-2021-5683-0040967
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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, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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-2021-5683-0040968
Page 130 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040969
Page 131 of 457
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
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Page 132 of 457
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040971
Page 133 of 457
***Confidential***
Header Text: c4591001
Visit: BOOSTER_EOT - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040972
Page 134 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Aug/11/2020
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040973
Page 135 of 457
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040974
Page 136 of 457
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040975
Page 137 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJun-10-2020 08:02:00 (UTC-05:00)
Eastern Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040976
Page 138 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040977
Page 139 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040978
Page 140 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040979
Page 141 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040980
Page 142 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040981
Page 143 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040982
Page 144 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040983
Page 145 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040984
Page 146 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Jun-10-2020 08:02:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)No Current medications at this time
Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040985
Page 147 of 457
***Confidential***
Header Text: c4591001
Visit: V8A_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - BOOSTER -
Comments
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-11-2021 11:12:20 (UTC-05:00)
Eastern Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040986
Page 148 of 457
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
11Jan-20-2021 10:50:15 (UTC-05:00) Eastern
Time (US & Canada)Mary Criddle
(pfe.mcriddle)not known what type of antibiotic given.
not listed in brief after visit summary from
hospital.
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040987
Page 149 of 457
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Lauren
Mitchell N/A Dec-30-2020 07:53:49 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward
Walsh Approved Aug-24-2020 20:56:58 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, 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.
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040988
Page 150 of 457
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jun-05-2020
12:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
13 MAY 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jun-05-2020
12:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe.mmurphy)Data Entry:
STAGE 1 SENTINEL CO
HORTSInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040989
Page 151 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Jun-10-2020 07:57:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Jun/5/2020Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040990
Page 152 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject ID
Date Location User Value Reason
Jun-05-2020 12:08:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10031038Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jun-05-2020 12:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1967Screening Log
Entry
3. Sex:
Date Location User Value Reason
Jun-15-2020
15:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Josee
Robillard
(pfe.robilj01)Query 1: Closed MALE both in
InForm and
Impala
Jun-10-2020
09:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Query 1: Answered After checking
subject
information in
Impala for
10031038
subject gender is
reported as male.
This matches
what gender is
reported in
inform.
Jun-10-2020
09:22:57ACV0PFEINFP6000 Jeffrey
SignoraQuery 1: Opened DM QUERY:
There is a
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0040991
Page 153 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)(pfe.signoj01) mismatch
between the sex
reported in
InForm and the
sex report in
IMPALA. Please
review and
reconcile.
Jun-10-2020
07:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jun-10-2020 07:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jun-10-2020 07:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
WHITEInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040992
Page 154 of 457
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Jun-10-2020 07:57:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jun/5/2020Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040993
Page 155 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Desc
riptio
n:Male or female partic
ipants between the ag
es of 18 and 55 years,
inclusive, 65 and 85 y
ears, inclusive, or 18
and 85 years, inclusiv
e, at randomization (d
ependent upon study
stage)
Crite
rion
met?
:YES
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) EasternACV0PFEINFP6000 Megan
HelfData Entry:
1Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040994
Page 156 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf)
1.a Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 ye
ars, inclusive, or 18 and 85 y
ears, inclusive, at randomizat
ion (dependent upon study st
age)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclus
ion N
umbe
r:2Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040995
Page 157 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Crite
rion
Descr
iption
:Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideratio
ns, and other study pr
ocedures
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN02A00
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040996
Page 158 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Inclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Participants who are willing
and able to comply with all s
cheduled visits, vaccination p
lan, laboratory tests, lifestyle
considerations, and other stu
dy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040997
Page 159 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclu
sion
Num
ber:3
Crite
rion
Descr
iption
:Healthy participants
who are determined b
y medical history, ph
ysical examination, a
nd clinical judgment
of the investigator to
be eligible for inclusi
on in the study
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN03A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040998
Page 160 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Inclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inves
tigator to be eligible for inclu
sion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0040999
Page 161 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclus
ion N
umbe
r:4
Crite
rion
Descr
iption
:Capable of giving pe
rsonal signed inform
ed consent, which in
cludes compliance w
ith the requirements
and restrictions listed
in the ICD and in this
protocol
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN04A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041000
Page 162 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Inclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Capable of giving personal si
gned informed consent, whic
h includes compliance with t
he requirements and restrictio
ns listed in the ICD and in thi
s protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041001
Page 163 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclu
sion
Num
ber:1
Crite
rion
Descr
iption
:Other medical or psy
chiatric condition inc
l. recent (within past
year) or active suicid
al ideation/behavior/l
ab abnormality that
may increase the risk
of study participation
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Other medical or psychiatric
condition incl. recent (withinInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041002
Page 164 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
past year) or active suicidal i
deation/behavior/lab abnorm
ality that may increase the ris
k of study participation
2.a Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Known infection wi
th human immunod
eficiency virus (HI
V), hepatitis C virus
(HCV), or hepatitis
B virus (HBV)
Criteri
on met
?:NOInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041003
Page 165 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on ID:
(For Pf
izer us
e only)
:EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Known infection with human
immunodeficiency virus (HI
V), hepatitis C virus (HCV),
or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX02A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041004
Page 166 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclu
sion
Num
ber:3
Crite
rion
Descr
iption
:History of severe adv
erse reaction associat
ed with a vaccine an
d/or severe allergic r
eaction (eg, anaphyla
xis) to any componen
t of the study interve
ntion(s)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX03A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041005
Page 167 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
History of severe adverse rea
ction associated with a vacci
ne and/or severe allergic reac
tion (eg, anaphylaxis) to any
component of the study inter
vention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041006
Page 168 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:4
Criterion
Descriptio
n:Receipt of medi
cations intended
to prevent COV
ID-19
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX04A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041007
Page 169 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of medications inten
ded to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numb
er:5Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041008
Page 170 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n Descri
ption:Stages 1 and 2 onl
y: Previous clinica
l or microbiologic
al diagnosis of CO
VID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX05A00
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041009
Page 171 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
5Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Stages 1 and 2 only: Previous
clinical or microbiological di
agnosis of COVID-19Initial Entry
2.e Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX05A00Initial Entry
2.f
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:6Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041010
Page 172 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Sentinel participant
s in Stage 1 only: I
ndividuals at high r
isk for severe COV
ID-19 (full details i
n protocol)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX06A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041011
Page 173 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
6Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage
1 only: Individuals at high ris
k for severe COVID-19 (full
details in protocol)Initial Entry
2.f Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX06A01Initial Entry
2.g
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Excl
usion7Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041012
Page 174 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Num
ber:
Crite
rion
Desc
riptio
n:Sentinel participants i
n Stage 1 only: Indivi
duals currently worki
ng in occupations wit
h high risk of exposur
e to SARS-CoV-2 (eg
, healthcare worker, e
mergency response pe
rsonnel)
Crite
rion
met?
:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX07A00
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041013
Page 175 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
7Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage
1 only: Individuals currently
working in occupations with
high risk of exposure to SAR
S-CoV-2 (eg, healthcare wor
ker, emergency response pers
onnel)Initial Entry
2.g Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX07A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041014
Page 176 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclu
sion N
umbe
r:8
Criter
ion De
scripti
on:Immunocompromise
d individuals with kn
own or suspected im
munodeficiency, as d
etermined by history
and/or laboratory/ph
ysical examination
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX08A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041015
Page 177 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
8Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Immunocompromised individ
uals with known or suspected
immunodeficiency, as determ
ined by history and/or laborat
ory/physical examinationInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX08A00Initial Entry
2.i
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) EasternACV0PFEINFP6000 Megan
HelfData Entry:
Exclusi9Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041016
Page 178 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf) on Nu
mber:
Criteri
on Des
criptio
n:Individuals with a h
istory of autoimmun
e disease or an activ
e autoimmune disea
se requiring therape
utic intervention
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX09A00
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041017
Page 179 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.i Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
9Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Individuals with a history of
autoimmune disease or an act
ive autoimmune disease requi
ring therapeutic interventionInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX09A00Initial Entry
2.j
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclu
sion10Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041018
Page 180 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Numb
er:
Criter
ion D
escrip
tion:Bleeding diathesis or
condition associated
with prolonged bleed
ing that would, in the
opinion of the investi
gator, contraindicate
intramuscular injecti
on
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX10A00
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041019
Page 181 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.j Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
10Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Bleeding diathesis or conditi
on associated with prolonged
bleeding that would, in the o
pinion of the investigator, co
ntraindicate intramuscular inj
ectionInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX10A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041020
Page 182 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
2.k
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion N
umber:11
Criterion D
escription:Women who a
re pregnant or
breastfeeding
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX11A00Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041021
Page 183 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.k Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
11Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Women who are pregnant or
breastfeedingInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX11A00Initial Entry
2.l
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:12Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041022
Page 184 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion
Descriptio
n:Previous vacci
nation with any
coronavirus va
ccine
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX12A00
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041023
Page 185 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.l Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
12Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Previous vaccination with an
y coronavirus vaccineInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX12A00Initial Entry
2.m
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:13Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041024
Page 186 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Desc
ription:Subjects who recei
ve immunosuppres
sive therapy, such a
s cytotoxic agents
or systemic cortico
steroids
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX13A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041025
Page 187 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.m Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
13Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Subjects who receive immun
osuppressive therapy, such a
s cytotoxic agents or systemi
c corticosteroidsInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX13A01Initial Entry
2.n
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) EasternACV0PFEINFP6000 Megan
HelfData Entry:
Exclusi 14Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041026
Page 188 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf) on Num
ber:
Criterio
n Descri
ption:Sentinel participan
ts in Stage 1 only:
Regular receipt of
inhaled/nebulized
corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX22A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041027
Page 189 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.n Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
14Initial Entry
2.n Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage
1 only: Regular receipt of in
haled/nebulized corticosteroi
dsInitial Entry
2.n Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.n Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX22A01Initial Entry
2.o
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) EasternACV0PFEINFP6000 Megan
HelfData Entry:
Exclu15Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041028
Page 190 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf) sion
Numb
er:
Criter
ion D
escrip
tion:Receipt of blood/pla
sma products or im
munoglobulin, from
60 days before study
intervention adminis
tration or planned re
ceipt throughout the
study
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX14A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041029
Page 191 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.o Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
15Initial Entry
2.o Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study inte
rvention administration or pl
anned receipt throughout the
studyInitial Entry
2.o Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.o Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX14A01Initial Entry
2.p
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041030
Page 192 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclus
ion Nu
mber:16
Criteri
on Des
criptio
n:Participation in othe
r studies involving s
tudy intervention wi
thin 28 days prior to
study entry and/or d
uring study particip
ation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX15A01Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041031
Page 193 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.p Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
16Initial Entry
2.p Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study par
ticipationInitial Entry
2.p Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.p Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX15A01Initial Entry
2.q
Date Location User Value Reason
Jun-10-2020 07:58:21 ACV0PFEINFP6000 Megan Data Entry: Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041032
Page 194 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)Helf
(pfe.ahelf)Exclusi
on Num
ber:17
Criteri
on Desc
ription:Previous participat
ion in other studies
involving study int
ervention containi
ng lipid nanopartic
les
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX16A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041033
Page 195 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.q Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
17Initial Entry
2.q Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Previous participation in oth
er studies involving study int
ervention containing lipid na
noparticlesInitial Entry
2.q Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.q Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX16A01Initial Entry
2.r
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) EasternACV0PFEINFP6000 Megan
HelfData Entry:
Exclus18Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041034
Page 196 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf) ion Nu
mber:
Criter
ion De
scripti
on:Sentinel participants
in Stage 1 only: Pos
itive serological test
for SARS-CoV-2 Ig
M and/or IgG antib
odies at the screenin
g visit
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX17A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041035
Page 197 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.r Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
18Initial Entry
2.r Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage
1 only: Positive serological t
est for SARS-CoV-2 IgM an
d/or IgG antibodies at the scr
eening visitInitial Entry
2.r Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.r Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX17A01Initial Entry
2.s
Date Location User Value Reason
Jun-10-2020 07:58:21 ACV0PFEINFP6000 Megan Data Entry: Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041036
Page 198 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)Helf
(pfe.ahelf)Excl
usio
n Nu
mber
:19
Crite
rion
Desc
ripti
on:Sentinel participants i
n Stage 1 only: Scree
ning hematology/bloo
d chemistry lab >=Gr
ade 1 abnormality. Ex
cept Bilirubin, other s
table Grade1 abnorm
alities may be conside
red eligible by Investi
gator
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX18A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041037
Page 199 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.s Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
19Initial Entry
2.s Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage
1 only: Screening hematolog
y/blood chemistry lab >=Gra
de 1 abnormality. Except Bili
rubin, other stable Grade1 ab
normalities may be considere
d eligible by InvestigatorInitial Entry
2.s Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.s Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX18A01Initial Entry
2.t
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041038
Page 200 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Excl
usion
Num
ber:20
Crite
rion
Desc
ripti
on:Sentinel participants i
n Stage 1 only: Positi
ve test for HIV, hepat
itis B surface antigen
(HBsAg), hepatitis B
core antibodies (HBc
Abs), or hepatitis C v
irus antibodies (HCV
Abs) at screening visi
t
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX19A01Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041039
Page 201 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.t Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
20Initial Entry
2.t Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage
1 only: Positive test for HIV,
hepatitis B surface antigen (
HBsAg), hepatitis B core ant
ibodies (HBc Abs), or hepati
tis C virus antibodies (HCV
Abs) at screening visitInitial Entry
2.t Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.t Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX19A01Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041040
Page 202 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
2.u
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclus
ion Nu
mber:21
Criter
ion De
scripti
on:Sentinel participants
in Stage 1 only: SA
RS-CoV-2 NAAT-p
ositive nasal swab
within 24 hours bef
ore receipt of study
intervention
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX20A01Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041041
Page 203 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.u Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
21Initial Entry
2.u Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage
1 only: SARS-CoV-2 NAAT-
positive nasal swab within 2
4 hours before receipt of stud
y interventionInitial Entry
2.u Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.u Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX20A01Initial Entry
2.v
Date Location User Value Reason
Jun-10-2020 07:58:21 ACV0PFEINFP6000 Megan Data Entry: Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041042
Page 204 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)Helf
(pfe.ahelf)Exclu
sion
Num
ber:22
Crite
rion
Descr
iptio
n:Investigator site staff
or Pfizer employees
directly involved in t
he conduct of the stu
dy, site staff otherwis
e supervised by the i
nvestigator, and their
respective family me
mbers
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX21A01
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041043
Page 205 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit
Trail History
Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.v Exclusion Number:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
22Initial Entry
2.v Criterion Description:
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Investigator site staff or Pfiz
er employees directly involv
ed in the conduct of the stud
y, site staff otherwise supervi
sed by the investigator, and t
heir respective family memb
ersInitial Entry
2.v Criterion met?
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.v Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jun-10-2020 07:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX21A01Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041044
Page 206 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jun-10-2020 07:58:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jun/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jun-10-2020 07:58:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jun-10-2020 07:58:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041045
Page 207 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Jun-10-2020 07:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Elevated Ch
olesterol
Start Date: UNK/UNK/
2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jun-10-2020 07:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jun-10-2020 07:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Elevated CholesterolInitial Entry
1.a Start Date:
Date Location User Value Reason
Jun-10-2020 07:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2014Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041046
Page 208 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.a Ongoing:
Date Location User Value Reason
Jun-10-2020 07:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jun-10-2020 07:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Chronic Lowe
r Back Pain
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041047
Page 209 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Jun-10-2020 07:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jun-10-2020 07:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Chronic Lower Back PainInitial Entry
1.b Start Date:
Date Location User Value Reason
Jun-10-2020 07:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jun-10-2020 07:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Jun-10-2020 08:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041048
Page 210 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Histo
ry Term:Chronic Gro
in Pain
Start Date: UNK/UNK/
2018
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Jun-10-2020 08:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jun-10-2020 08:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Chronic Groin PainInitial Entry
1.c Start Date:
Date Location User Value Reason
Jun-10-2020 08:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jun-10-2020 08:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.d
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041049
Page 211 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jun-10-2020 08:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:Hernia Surge
ry
Start Date: UNK/UNK/2
017
Ongoing: NO
End Date:
UNK/UN
K/2017Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041050
Page 212 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Jun-10-2020 08:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jun-16-2020
11:48:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe.hassaa38)Query 1: Closed Response satisfies
query
Jun-16-2020
09:25:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Emily Pierce
(pfe.epierce)Query 1: Answered Original value is
correct
Jun-12-2020
10:39:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ahmed
Hassan
(pfe.hassaa38)Query 1: Opened Per CRF completion
requirements section
8.6, please can the
condition that led to
the
surgery/interventional
procedure being
carried out, be listed
as a separate medical
history entry. thanks
Jun-10-2020
08:00:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Data Entry:
Hernia SurgeryInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041051
Page 213 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Start Date:
Date Location User Value Reason
Jun-10-2020 08:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jun-10-2020 08:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.e
Date Location User Value Reason
Jun-10-2020 09:09:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Line/MH Num
ber:5
Medical Histo
ry Term:Penicillin
Allergy
Start Date: UNK/UNK
/1972
Ongoing: YESTranscription
Error
Jun-10-2020 08:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Penicillin
Start Date: UNK/UN
K/1972
Ongoing: YESInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041052
Page 214 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Line/MH Number:
Date Location User Value Reason
Jun-10-2020 08:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Jun-10-2020
10:38:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy has
been closed.
Jun-10-2020
09:09:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Jun-10-2020
09:09:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Data
Entry
:
Penici
llin A
llergyTranscription
Error
Jun-10-2020
08:43:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
1: Op
enedClarify
PENICILLIN as
follows.... Drug
only reported.
Are you
reporting
ALLERGY TO?
INTERACTION
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041053
Page 215 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
WITH? Other?
Please clarify
and edit term. If
reporting
therapeutic use,
please move the
term to the
appropriate
medication
module. Thank
you.
Jun-10-2020
08:01:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Data
Entry
:
Penici
llinInitial Entry
1.e Start Date:
Date Location User Value Reason
Jun-10-2020 08:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/1972Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jun-10-2020 08:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Jun-16-2020 09:25:55 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041054
Page 216 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Nu
mber:6
Medical Histo
ry Term:hernia Injury
Start Date: UNK/UNK/2
017
Ongoing: NO
End Date:
UNK/UN
K/2017
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041055
Page 217 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Line/MH Number:
Date Location User Value Reason
Jun-16-2020 09:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jun-16-2020 09:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
hernia InjuryInitial Entry
1.f Start Date:
Date Location User Value Reason
Jun-16-2020 09:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
UNK/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Jun-16-2020 09:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041056
Page 218 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is
unknown, enter the full trade or proprietary name. Include clarifying information in the Medication text
(e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
5. Dose:
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041057
Page 219 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: CONCOMITANT MEDICATIONS - BASELINE - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
6. Dose Unit:
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
8. Route:
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
9. Start Date:
Date Location User Value Reason
Jun-10-2020 08:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041058
Page 220 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:46 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Exam Date:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jun/5/2020Initial Entry
2.a
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Body Syste
m Examine
d:GENERAL A
PPEARANCE
Result: NORMALInitial Entry
2.a Body System Examined:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
GENERAL APPEARANCEInitial Entry
2.a Result:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.b
Date Location User Value Reason
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041059
Page 221 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:46 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Body System Exa
mined:SKIN
Result: NORM
ALInitial Entry
2.b Body System Examined:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
SKINInitial Entry
2.b Result:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.c
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Body System Exa
mined:HEAD
Result: NORM
ALInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041060
Page 222 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:46 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Body System Examined:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
HEADInitial Entry
2.c Result:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.d
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Body System Exa
mined:EYES
Result: NORM
ALInitial Entry
2.d Body System Examined:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EYESInitial Entry
2.d Result:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
090177e196ae3d67\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041061
Page 223 of 457
***Confidential***
Header Text: c4591001
Visit: SCR Form: PHYSICAL EXAMINATION - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:46 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031038 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Body System Exa
mined:EARS
Result: NORM
ALInitial Entry
2.e Body System Examined:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EARSInitial Entry
2.e Result:
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.f
Date Location User Value Reason
Jun-10-2020 08:02:55
(UTC-05:00) Eastern
Time (U
…[truncated]