125742 S1 M5 CRF c4591001 1003 10031065

Document text

Page 1 of 407
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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
version27 MAY 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 1 SENTINEL COHORTS
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041297
Page 2 of 407
***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: 10031065 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/12/2020
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041298
Page 3 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031065]
2.Birth Date: /1968
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0041299
Page 4 of 407
***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: 10031065 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/12/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041300
Page 5 of 407
***Confidential***
 
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041301
Page 6 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV),
or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 5
Criterion Description: Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX05A00
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041302
Page 7 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041303
Page 8 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041304
Page 9 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041305
Page 10 of 407
***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: 10031065 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/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0041306
Page 11 of 407
***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: 10031065 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: Not Applicable
[ ]Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]Comments
Start Date: Not Applicable
//Comments
Ongoing: Not Applicable Comments
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Wears Glasses]
Start Date: UNK/UNK/1982
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Deviated Septum - Nasal Surgery]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
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FDA-CBER-2021-5683-0041307
Page 12 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
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FDA-CBER-2021-5683-0041308
Page 13 of 407
***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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041309
Page 14 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jun/12/2020
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
2.iBody System Examined: LUNGS
Result: NORMAL
2.jBody System Examined: ABDOMEN
Result: NORMAL
2 kBody System Examined: MUSCULOSKELETAL
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041310
Page 15 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2 mBody System Examined: NEUROLOGICAL
Result: NORMAL
2 nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041311
Page 16 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jun/12/2020
2.Weight: [154.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [24.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
Systolic: [119]
Diastolic: [77]
BP Position: SITTING
Pulse: [74]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041312
Page 17 of 407
***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: 10031065 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/12/2020
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 [BNBTS3]
5.bSample ID [BNBTS4]
5.cSample ID [BNYG2B]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041313
Page 18 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Coll
ectionSpecimen
TypeAssay Code and Description Device Type ResultForm Instanc
e
 1.Jun/12/2020  BLOOD  SEVERE ACUTE RESP SYNDROME C
ORONAVIRUS 2 SARS-COV-2 DIAGNOS
TIC TEST NEGATI
VE Repeating
Pages
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041314
Page 19 of 407
***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: 10031065 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/12/2020
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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041315
Page 20 of 407
***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: 10031065 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/12/2020
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041316
Page 21 of 407
***Confidential***
 
Header Text: c4591001
Visit: SCR Form: LAB URINALYSIS - PREGNANCY TEST
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jun/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041317
Page 22 of 407
***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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041318
Page 23 of 407
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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: 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
2.iBody System Examined: LUNGS
Result: NORMAL
2.jBody System Examined: ABDOMEN
Result: NORMAL
2 kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041319
Page 24 of 407
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2 mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2 nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041320
Page 25 of 407
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: VITAL SIGNS
Form Version: 19-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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: [98.1]
Unit: F
Temperature Location: FOREHEAD
Systolic: [118]
Diastolic: [59]
BP Position: SITTING
Pulse: [95]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041321
Page 26 of 407
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_S Form: LAB URINALYSIS - PREGNANCY TEST
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jun/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041322
Page 27 of 407
***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: 10031065 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/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 [BN8F6Z]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041323
Page 28 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jun/24/202
0 SWABBED M
ATERIAL NASAL CAVITY  SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041324
Page 29 of 407
***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: 10031065 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/24/2020
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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041325
Page 30 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Jun/24/2020
2.Randomization Number: [2303]
3.Randomization Group: [Stage 1, Age 18 to 55, Medium dose level (30mcg), 21 Day (BNT162b2 or PBO)]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041326
Page 31 of 407
***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: 10031065 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 DoseMedium dose level (30mcg)
4.Select appropriate response -
Randomization Dose Group21 Day
5.Select appropriate response - BNT
Number(BNT162b2 or PBO)
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041327
Page 32 of 407
***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: 10031065 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 [BN8F72]
5.bSample ID [BN8F73]
5.cSample ID [BN8F74]
5.dSample ID [BN8F75]
5.eSample ID [BN8F76]
5 fSample ID [BNYG98]
5.gSample ID [BNYG99]
5.hSample ID [BNYG9B]
5.iSample ID [BNYG9C]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041328
Page 33 of 407
***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: 10031065 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/24/2020 11:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [0.5]
9.Unit: mL
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041329
Page 34 of 407
***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: 10031065 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/25/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041330
Page 35 of 407
***Confidential***
 
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jun/25/2020
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
2.iBody System Examined: LUNGS
Result: NOT DONE
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2 kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041331
Page 36 of 407
***Confidential***
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: PHYSICAL EXAMINATION
Form Version: 19-Jun-2020 21:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2 mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2 nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041332
Page 37 of 407
***Confidential***
 
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: VITAL SIGNS
Form Version: 19-Jun-2020 21:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jun/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: FOREHEAD
Systolic: [107]
Diastolic: [59]
BP Position: SITTING
Pulse: [83]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041333
Page 38 of 407
***Confidential***
 
Header Text: c4591001
Visit: V2_DAY2_POSTVAX1_S Form: CENTRAL LAB SAMPLE COLLECTION
Form Version: 19-Jun-2020 21:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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/25/2020
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041334
Page 39 of 407
***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: 10031065 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/1/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041335
Page 40 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/1/2020
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
2.iBody System Examined: LUNGS
Result: NOT DONE
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2 kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041336
Page 41 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2 mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2 nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041337
Page 42 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: EAR
Systolic: [111]
Diastolic: [62]
BP Position: SITTING
Pulse: [77]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041338
Page 43 of 407
***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: 10031065 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/1/2020
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041339
Page 44 of 407
***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: 10031065 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/1/2020
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 [BN8D04]
5.bSample ID [BN8D05]
5.cSample ID [BN8D06]
5.dSample ID [BN8D07]
5.eSample ID [BN8D08]
5 fSample ID [BNYG7F]
5.gSample ID [BNYG7G]
5.hSample ID [BNYG7H]
5.iSample ID [BNYFPY]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041340
Page 45 of 407
***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: 10031065 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/15/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041341
Page 46 of 407
***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: 10031065 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
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041342
Page 47 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041343
Page 48 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/15/2020
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
2.iBody System Examined: LUNGS
Result: NORMAL
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2 kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041344
Page 49 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2 mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2 nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041345
Page 50 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: FOREHEAD
Systolic: [108]
Diastolic: [70]
BP Position: SITTING
Pulse: [81]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041346
Page 51 of 407
***Confidential***
 
Header Text: c4591001
Visit: V4_WEEK3_VAX2_S Form: LAB URINALYSIS - PREGNANCY TEST
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jul/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041347
Page 52 of 407
***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: 10031065 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/15/2020
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 [BGJFYF]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041348
Page 53 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jul/15/2020
 SWABBED M
ATERIAL NASAL CAVITY  SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041349
Page 54 of 407
***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: 10031065 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/15/2020
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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041350
Page 55 of 407
***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: 10031065 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/15/2020
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041351
Page 56 of 407
***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: 10031065 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/15/2020
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 [BGJFYH]
5.bSample ID [BGJFYJ]
5.cSample ID [BGJFYK]
5.dSample ID [BGJFYL]
5.eSample ID [BGJFYM]
5 fSample ID [BNYF8X]
5.gSample ID [BNYF8Y]
5.hSample ID [BNYF8Z]
5.iSample ID [BNYF90]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041352
Page 57 of 407
***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: 10031065 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/15/2020 09:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [0.5]
9.Unit: mL
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041353
Page 58 of 407
***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: 10031065 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/22/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041354
Page 59 of 407
***Confidential***
 
Header Text: c4591001
Visit: V5_WEEK1_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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/22/2020
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
2.iBody System Examined: LUNGS
Result: NOT DONE
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2 kBody System Examined: MUSCULOSKELETAL
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041355
Page 60 of 407
***Confidential***
Header Text: c4591001
Visit: V5_WEEK1_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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2 mBody System Examined: NEUROLOGICAL
Result: NORMAL
2 nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041356
Page 61 of 407
***Confidential***
 
Header Text: c4591001
Visit: V5_WEEK1_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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: FOREHEAD
Systolic: [103]
Diastolic: [63]
BP Position: SITTING
Pulse: [69]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041357
Page 62 of 407
***Confidential***
 
Header Text: c4591001
Visit: V5_WEEK1_POSTVAX2_S Form: CENTRAL LAB SAMPLE COLLECTION
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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/22/2020
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041358
Page 63 of 407
***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: 10031065 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/22/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGJG6Z]
5.bSample ID [BGJG70]
5.cSample ID [BGJG71]
5.dSample ID [BGJG72]
5.eSample ID [BGJG73]
5 fSample ID [BNYFG5]
5.gSample ID [BNYFG6]
5.hSample ID [BNYFG7]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041359
Page 64 of 407
***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: 10031065 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/29/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041360
Page 65 of 407
***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: 10031065 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
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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041361
Page 66 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041362
Page 67 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Physical Examination
1.Exam Date: Jul/29/2020
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
2.iBody System Examined: LUNGS
Result: NOT DONE
2.jBody System Examined: ABDOMEN
Result: NOT DONE
2 kBody System Examined: MUSCULOSKELETAL
Result: NOT DONE
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041363
Page 68 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.lBody System Examined: EXTREMITIES
Result: NORMAL
2 mBody System Examined: NEUROLOGICAL
Result: NOT DONE
2 nBody System Examined: LYMPH NODES
Result: NORMAL
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041364
Page 69 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: FOREHEAD
Systolic: [100]
Diastolic: [70]
BP Position: SITTING
Pulse: [84]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041365
Page 70 of 407
***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: 10031065 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/29/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGJWB4]
5.bSample ID [BGJWB5]
5.cSample ID [BGJWB6]
5.dSample ID [BGJWB7]
5.eSample ID [BGJWB8]
5 fSample ID [BNYFK6]
5.gSample ID [BNYFK7]
5.hSample ID [BNYFK8]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041366
Page 71 of 407
***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: 10031065 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/19/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041367
Page 72 of 407
***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: 10031065 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/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[low draw]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57GS]
5.bSample ID [BP57GT]
5.cSample ID [BP57GV]
5.dSample ID [BP57GW]
5.eSample ID [BP57GX]
5 fSample ID [BKDZ5T]
5.gSample ID [BKDZ5V]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041368
Page 73 of 407
***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: 10031065 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 Jan/8/2021
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041369
Page 74 of 407
***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: 10031065 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:
Jan/8/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLH4]
5.bSample ID [BNWKSX]
5.cSample ID [BNWKSY]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041370
Page 75 of 407
***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: 10031065 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/3/2021
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041371
Page 76 of 407
***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: 10031065 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
Mar/3/2021
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041372
Page 77 of 407
***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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041373
Page 78 of 407
***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: 10031065 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 :Mar/3/2021
2.Phase of Disposition: REPEAT SCREENING 2
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041374
Page 79 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Mar/3/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041375
Page 80 of 407
***Confidential***
 
Header Text: c4591001
Visit: V8A_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/3/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041376
Page 81 of 407
***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: 10031065 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/3/2021
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 [BPYLTM]
5.bSample ID [BVR36V]
5.cSample ID [BVR36W]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041377
Page 82 of 407
***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: 10031065 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:
Mar/3/2021
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 [BPYLTK]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041378
Page 83 of 407
***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: 10031065 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: Mar/3/2021 08:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041379
Page 84 of 407
***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: 10031065 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/10/2021
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041380
Page 85 of 407
***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: 10031065 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/10/2021
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 [BPYLVT]
5.bSample ID [BVR394]
5.cSample ID [BVR395]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041381
Page 86 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041382
Page 87 of 407
***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: 10031065 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 [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041383
Page 88 of 407
***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: 10031065 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?
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041384
Page 89 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041385
Page 90 of 407
***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: 10031065 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 [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041386
Page 91 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041387
Page 92 of 407
***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: 10031065 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 [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041388
Page 93 of 407
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041389
Page 94 of 407
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041390
Page 95 of 407
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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 [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041391
Page 96 of 407
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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 [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041392
Page 97 of 407
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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?
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041393
Page 98 of 407
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041394
Page 99 of 407
***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: 10031065 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:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041395
Page 100 of 407
***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: 10031065 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 [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041396
Page 101 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jul/16/2020Form: 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: 10031065 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/16/2020
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041397
Page 102 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jul/16/2020Form: UNPLANNED VISIT
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041398
Page 103 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jul/16/2020Form: CONTACT OUTCOME - UNPLANNED
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Jul/16/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Pt. Report: mild fever of (100.4-101.1 degree F), mild pain at injection site, severe
fatigue and moderate headache. PI determined no site visit is clinically needed.]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041399
Page 104 of 407
***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: 10031065 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/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041400
Page 105 of 407
***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: 10031065 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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041401
Page 106 of 407
***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: 10031065 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:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041402
Page 107 of 407
***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: 10031065 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 [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041403
Page 108 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ongo
ingForm Instance
 1.ADVERSE EVEN
T 1  right arm pain
 Jul/29/2020 09:40  YES  Repeating
Pages
 2.ADVERSE EVEN
T 2  neuritis  Jul/29/2020 UNK:UN
K YES  Repeating
Pages
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041404
Page 109 of 407
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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)[right arm pain]
4.Start Date Time: Jul/29/2020 09:40
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041405
Page 110 of 407
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041406
Page 111 of 407
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[neuritis]
4.Start Date Time: Jul/29/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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?
NO
Did this serious event result in persistent or significant disability/incapacity?
YES
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[related to study blood draw]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041407
Page 112 of 407
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT 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[2020449114]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041408
Page 113 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041409
Page 114 of 407
***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: 10031065 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[ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041410
Page 115 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041411
Page 116 of 407
***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: 10031065 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: //
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041412
Page 117 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041413
Page 118 of 407
***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: 10031065 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?
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041414
FDA-CBER-2021-5683-0041415
Page 120 of 407
***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: 10031065 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?
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041416
FDA-CBER-2021-5683-0041417
Page 122 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041418
Page 123 of 407
***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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041419
Page 124 of 407
***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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041420
Page 125 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041421
Page 126 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041422
Page 127 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041423
Page 128 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10031065 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?
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041424
Page 129 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041425
Page 130 of 407
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041426
Page 131 of 407
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 10031065 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 Jan/8/2021
2.Erroneous Visit
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041427
Page 132 of 407
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041428
Page 133 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041429
Page 134 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041430
Page 135 of 407
***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: 10031065 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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041431
Page 136 of 407
***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: 10031065 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: [ ]
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041432
Page 137 of 407
***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: 10031065 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/19/2020
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041433
Page 138 of 407
***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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041434
Page 139 of 407
***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: 10031065 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
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041435
Page 140 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - Comments
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.aJun-22-2020 07:18:47 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line to be removed
Not Applicable
1.aJun-22-2020 07:18:25 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)line should be removed
1.aJun-16-2020 07:31:40 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line 2 overlap
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041436
Page 141 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - Comments
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.aJun-22-2020 07:18:47 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line to be removed
Not Applicable
1.aJun-22-2020 07:18:25 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)line should be removed
1.aJun-16-2020 07:31:40 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line 2 overlap
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041437
Page 142 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - Comments
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.aJun-22-2020 07:18:47 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line to be removed
Not Applicable
1.aJun-22-2020 07:18:25 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)line should be removed
1.aJun-16-2020 07:31:40 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line 2 overlap
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041438
Page 143 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: GENERAL MEDICAL HISTORY - Comments
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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1.aJun-22-2020 07:18:47 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line to be removed
Not Applicable
1.aJun-22-2020 07:18:25 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)line should be removed
1.aJun-16-2020 07:31:40 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Line 2 overlap
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041439
Page 144 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041440
Page 145 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041441
Page 146 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041442
Page 147 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041443
Page 148 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041444
Page 149 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041445
Page 150 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041446
Page 151 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
7Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041447
Page 152 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
8Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041448
Page 153 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
9Jun-12-2020 13:34:14 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)No medications at this time
Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041449
Page 154 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-03-2021 10:42:06 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041450
Page 155 of 407
***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: 10031065 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 Nov-30-2020 07:38:31 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Nov-13-2020 13:24:11 (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.
Mary Criddle  N/A Nov-12-2020 15:00:11 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Nov-03-2020 16:55:32 (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.
Mary Criddle  N/A Oct-28-2020 11:30:54 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041451
Page 156 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
N/A
Edward Walsh  Approved Aug-24-2020 21:20:25 (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.
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041452
Page 157 of 407
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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-12-2020 13:24:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
27 MAY 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jun-12-2020 13:24:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
STAGE 1 SENTINEL COHORTSInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041453
Page 158 of 407
***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: 10031065 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-12-2020 13:25:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
OBTAINED
Date Written Consent Obtained
Jun/12/2020Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041454
Page 159 of 407
***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: 10031065 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-12-2020 13:24:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10031065Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jun-12-2020 13:24:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1968Screening Log Entry
3. Sex:
Date Location User Value Reason
Jun-12-2020 13:25:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jun-12-2020 13:25:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jun-12-2020 13:25:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
WHITEInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0041455
Page 160 of 407
***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: 10031065 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-12-2020 13:25:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Jun/12/2020Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041456
Page 161 of 407
***Confidential***
 
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 ye
ars, inclusive, or 18 and 85 ye
ars, inclusive, at randomizatio
n (dependent upon study stag
e)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Male or female participants between th
e ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 y
ears, inclusive, at randomization (depe
ndent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041457
Page 162 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Desc
ription:Participants who are willing
and able to comply with all s
cheduled visits, vaccination
plan, laboratory tests, lifestyl
e considerations, and other st
udy procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN02A00Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041458
Page 163 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Inclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, vac
cination plan, laboratory tests, lifestyle
considerations, and other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inve
stigator to be eligible for incl
usion in the studyInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041459
Page 164 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Healthy participants who are determin
ed by medical history, physical examin
ation, and clinical judgment of the inve
stigator to be eligible for inclusion in t
he studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Inclusi
on Nu4Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041460
Page 165 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
mber:
Criteri
on Desc
ription:Capable of giving personal si
gned informed consent, whic
h includes compliance with t
he requirements and restricti
ons listed in the ICD and in t
his protocol
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Capable of giving personal signed info
rmed consent, which includes complia
nce with the requirements and restricti
ons listed in the ICD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
IN04A00Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041461
Page 166 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal i
deation/behavior/lab abnorm
ality that may increase the ris
k of study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or active
suicidal ideation/behavior/lab abnorma
lity that may increase the risk of study
participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041462
Page 167 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numbe
r:2
Criterion
Descripti
on:Known infection with hum
an immunodeficiency virus
(HIV), hepatitis C virus (H
CV), or hepatitis B virus (
HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041463
Page 168 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Known infection with human immuno
deficiency virus (HIV), hepatitis C vir
us (HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription: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)
Criteri
on met
?:NOInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041464
Page 169 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on ID: (
For Pfi
zer use
only):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
History of severe adverse reaction asso
ciated with a vaccine and/or severe alle
rgic reaction (eg, anaphylaxis) to any c
omponent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medication
s intended to prevent
COVID-19Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041465
Page 170 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of medications intended to pre
vent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:5
Criterion D
escription:Stages 1 and 2 only: Pre
vious clinical or microbi
ological diagnosis of CO
VID-19
Criterion
met?:NOInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041466
Page 171 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion I
D: (For Pfi
zer use onl
y):EX05A00
2.e Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Stages 1 and 2 only: Previous clinical
or microbiological diagnosis of COVI
D-19Initial Entry
2.e Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX05A00Initial Entry
2.f
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:6
Criterion
Descripti
on:Sentinel participants in Sta
ge 1 only: Individuals at hi
gh risk for severe COVID-
19 (full details in protocol)
Criterion
met?:NOInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041467
Page 172 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion
ID: (For
Pfizer use
only):EX06A01
2.f Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage 1 only: I
ndividuals at high risk for severe COV
ID-19 (full details in protocol)Initial Entry
2.f Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX06A01Initial Entry
2.g
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclus
ion Nu
mber:7Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041468
Page 173 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Sentinel participants in Stage
1 only: Individuals currently
working in occupations with
high risk of exposure to SAR
S-CoV-2 (eg, healthcare work
er, emergency response perso
nnel)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX07A00
2.g Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage 1 only: I
ndividuals currently working in occupa
tions with high risk of exposure to SA
RS-CoV-2 (eg, healthcare worker, eme
rgency response personnel)Initial Entry
2.g Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX07A00Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041469
Page 174 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Num
ber:8
Criterio
n Descri
ption:Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as det
ermined by history and/or la
boratory/physical examinati
on
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041470
Page 175 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Immunocompromised individuals with
known or suspected immunodeficiency
, as determined by history and/or labor
atory/physical examinationInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX08A00Initial Entry
2.i
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numbe
r:9
Criterion
Descripti
on:Individuals with a history o
f autoimmune disease or an
active autoimmune disease
requiring therapeutic interv
ention
Criterion
met?:NOInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041471
Page 176 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion
ID: (For
Pfizer us
e only):EX09A00
2.i Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Individuals with a history of autoimmu
ne disease or an active autoimmune dis
ease requiring therapeutic interventionInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX09A00Initial Entry
2.j
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Num
ber:10Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041472
Page 177 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Desc
ription:Bleeding diathesis or conditi
on associated with prolonged
bleeding that would, in the o
pinion of the investigator, co
ntraindicate intramuscular in
jection
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX10A00
2.j Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Bleeding diathesis or condition associa
ted with prolonged bleeding that woul
d, in the opinion of the investigator, co
ntraindicate intramuscular injectionInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX10A00Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041473
Page 178 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Num
ber:11
Criterion Descri
ption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00Initial Entry
2.k Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Women who are pregnant or breastfee
dingInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX11A00Initial Entry
2.l
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041474
Page 179 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Nu
mber:12
Criterion Desc
ription:Previous vaccination
with any coronavirus
vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00Initial Entry
2.l Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Previous vaccination with any coronav
irus vaccineInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX12A00Initial Entry
2.m
Date Location User Value Reason
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041475
Page 180 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:13
Criterion
Descripti
on:Subjects who receive imm
unosuppressive therapy, s
uch as cytotoxic agents or
systemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01Initial Entry
2.m Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Subjects who receive immunosuppress
ive therapy, such as cytotoxic agents o
r systemic corticosteroidsInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX13A01Initial Entry
2.n
Date Location User Value Reason
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041476
Page 181 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:14
Criterion
Descriptio
n:Sentinel participants in S
tage 1 only: Regular rece
ipt of inhaled/nebulized c
orticosteroids
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX22A01Initial Entry
2.n Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage 1 only:
Regular receipt of inhaled/nebulized c
orticosteroidsInitial Entry
2.n Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX22A01Initial Entry
2.o
Date Location User Value Reason
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041477
Page 182 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Num
ber:15
Criteri
on Desc
ription:Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study int
ervention administration or
planned receipt throughout t
he study
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX14A01Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041478
Page 183 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.o Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before
study intervention administration or pl
anned receipt throughout the studyInitial Entry
2.o Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX14A01Initial Entry
2.p
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studie
s involving study interventi
on within 28 days prior to s
tudy entry and/or during stu
dy participation
Criterio
n met?:NOInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041479
Page 184 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n ID: (F
or Pfizer
use only)
:EX15A01
2.p Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(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 part
icipationInitial Entry
2.p Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX15A01Initial Entry
2.q
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticlesInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041480
Page 185 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX16A01
2.q Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Previous participation in other studies
involving study intervention containin
g lipid nanoparticlesInitial Entry
2.q Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX16A01Initial Entry
2.r
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numb
er:18Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041481
Page 186 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n Descri
ption:Sentinel participants in Sta
ge 1 only: Positive serologi
cal test for SARS-CoV-2 Ig
M and/or IgG antibodies at
the screening visit
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX17A01
2.r Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage 1 only: P
ositive serological test for SARS-CoV-
2 IgM and/or IgG antibodies at the scr
eening visitInitial Entry
2.r Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX17A01Initial Entry
2.s
Date Location User Value Reason
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041482
Page 187 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclus
ion N
umber
:19
Criter
ion De
scripti
on:Sentinel participants in Stage
1 only: Screening hematology
/blood chemistry lab >=Grade
1 abnormality. Except Bilirub
in, other stable Grade1 abnor
malities may be considered el
igible by Investigator
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX18A01Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041483
Page 188 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.s Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage 1 only: S
creening hematology/blood chemistry
lab >=Grade 1 abnormality. Except Bil
irubin, other stable Grade1 abnormaliti
es may be considered eligible by Inves
tigatorInitial Entry
2.s Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX18A01Initial Entry
2.t
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclus
ion Nu
mber:20
Criter
ion De
scripti
on:Sentinel participants in Stage
1 only: Positive test for HIV,
hepatitis B surface antigen (H
BsAg), hepatitis B core antib
odies (HBc Abs), or hepatitis
C virus antibodies (HCV Abs
) at screening visitInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041484
Page 189 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX19A01
2.t Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage 1 only: P
ositive test for HIV, hepatitis B surface
antigen (HBsAg), hepatitis B core anti
bodies (HBc Abs), or hepatitis C virus
antibodies (HCV Abs) at screening vis
itInitial Entry
2.t Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX19A01Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041485
Page 190 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numb
er:21
Criterio
n Descri
ption:Sentinel participants in Stag
e 1 only: SARS-CoV-2 NA
AT-positive nasal swab wit
hin 24 hours before receipt
of study intervention
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX20A01Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041486
Page 191 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.u Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sentinel participants in Stage 1 only: S
ARS-CoV-2 NAAT-positive nasal swa
b within 24 hours before receipt of stu
dy interventionInitial Entry
2.u Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX20A01Initial Entry
2.v
Date Location User Value Reason
Jun-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Exclus
ion Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfize
r employees directly involve
d in the conduct of the study,
site staff otherwise supervise
d by the investigator, and thei
r respective family members
Criteri
on met
?:NOInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041487
Page 192 of 407
***Confidential***
Header Text: c4591001
Visit: SCR Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 06-Jun-2020 00:48 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on ID:
(For Pf
izer us
e only)
:EX21A01
2.v Exclusion Number:
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Investigator site staff or Pfizer employ
ees directly involved in the conduct of
the study, site staff otherwise supervis
ed by the investigator, and their respec
tive family membersInitial Entry
2.v Criterion met?
Date Location User Value Reason
Jun-12-2020 13:25:59
(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-12-2020 13:25:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
EX21A01Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041488
Page 193 of 407
***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: 10031065 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-12-2020 13:26:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Jun/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jun-12-2020 13:26:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jun-12-2020 13:26:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041489
Page 194 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Jul-02-2020 10:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Line/MH Number: Not Applicabl
e
Medical History Ter
m:Not Applicabl
e
Start Date: Not Applicabl
e
Ongoing: Not Applicabl
eNew Information
(DELETED)
Jun-22-2020 07:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: Not Applicabl
e
Medical History Ter
m:Not Applicabl
e
Start Date: Not Applicabl
e
Ongoing: Not Applicabl
eInitial Entry
Jun-22-2020 07:18:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Initial Entry
Jun-16-2020 07:31:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: Not Applicabl
e
Medical History Ter
m:Not Applicabl
e
Start Date: Not Applicabl
e
Ongoing: Not Applicabl
eInitial Entry
Jun-16-2020 07:31:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Changed Information
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041490
Page 195 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-16-2020 07:31:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing: YESChanged Information
Jun-16-2020 07:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number:
Medical History Ter
m:
Start Date: UNK/UNK/19
82
Ongoing: YESChanged Information
Jun-12-2020 13:32:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Wears Contacts
PRN
Start Date: UNK/UNK/1982
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-02-2020 10:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableNew Information
(DELETED)
Jun-22-2020 07:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jun-22-2020 07:18:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
Jun-16-2020 07:31:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jun-16-2020 07:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Changed Information
Jun-12-2020 13:32:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041491
Page 196 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-08-2020
13:16:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Gladys Noi TMS
Query
(pfe.noig_tmsquery)Query 5: Clo
sedResponse satisfies
query
Jul-02-2020
10:29:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Not Applica
bleNew Information
(DELETED)
Jul-02-2020
10:29:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: An
sweredNew Information
Jul-02-2020
09:27:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Josée Robillard tmsq
(pfe.robilj01_tmsq)Query 5: Rei
ssued:Opene
dIf line is not
applicable, please
select 'delete' at the
bottom of the page
rather than adding
NOT
APPLICABLE.
Jun-22-2020
10:37:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Query 5: An
sweredThis line needs to be
deleted. Therefore
not applicable.
Jun-22-2020
09:26:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query 5: Op
enedNull Term: Verbatim
term must not be
null/blank.
Jun-22-2020
08:27:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query 4: Clo
sedDiscrepancy has
been closed.
Jun-22-2020
07:18:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Query 4: An
sweredLine should be
removed
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041492
Page 197 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-22-2020
07:18:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Not Applica
bleInitial Entry
Jun-22-2020
07:18:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry: Initial Entry
Jun-19-2020
20:19:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query 4: Op
enedNull Term: Verbatim
term must not be
null/blank.
Jun-19-2020
19:21:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query 3: Clo
sedDiscrepancy has
been closed.
Jun-17-2020
01:03:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Derrick Newton
(pfe.newtod07)Query 2: Clo
sedResponse satisfies
query
Jun-16-2020
08:39:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Query 3: An
sweredOriginal value is
correct
Jun-16-2020
08:32:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query 3: Op
enedNull Term: Verbatim
term must not be
null/blank.
Jun-16-2020
07:31:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Not Applica
bleInitial Entry
Jun-16-2020
07:31:01
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  auto query
(autoquery)Query 2: An
sweredChanged
Information
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041493
Page 198 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada)
Jun-16-2020
07:31:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry: Changed
Information
Jun-16-2020
06:08:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Derrick Newton
(pfe.newtod07)Query 2: Op
enedThis Medical
History event
appears to be a
duplicate with
overlapping dates
with another
Medical History
event recorded on
line 2. Please review
if any updates are
needed. If no
updates are required,
please clarify.
Jun-16-2020
06:07:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Derrick Newton
(pfe.newtod07)Query 1: Clo
sedIncorrect Query Text
Jun-16-2020
06:05:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query 1: Op
enedDMW3858841;This
Medical History
event appears to be a
duplicate with
overlapping dates
with another
Medical History
event recorded on
line . Please review
if any updates are
needed. If no
updates are required,
please clarify.
Jun-12-2020
13:32:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Wears Conta
cts PRNInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041494
Page 199 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-02-2020 10:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableNew Information
(DELETED)
Jun-22-2020 07:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
Jun-22-2020 07:18:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry: Initial Entry
Jun-16-2020 07:31:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
Jun-16-2020 07:31:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry: Changed Information
Jun-12-2020 13:32:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/1982Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-02-2020 10:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableNew Information
(DELETED)
Jun-22-2020 07:18:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
Jun-22-2020 07:18:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry: Initial Entry
Jun-16-2020 07:31:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
Jun-16-2020 07:31:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry: Changed Information
Jun-12-2020 13:32:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.b
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041495
Page 200 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jun-12-2020 13:32:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Wears Glasses
Start Date: UNK/UNK/19
82
Ongoing: YESInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041496
Page 201 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.b Line/MH Number:
Date Location User Value Reason
Jun-12-2020 13:32:46
(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-16-2020
06:07:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Derrick Newton
(pfe.newtod07)Query 1: Clo
sedIncorrect Query text.
Jun-16-2020
06:05:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query 1: Op
enedDMW3858842;This
Medical History
event appears to be a
duplicate with
overlapping dates
with another
Medical History
event recorded on
line . Please review
if any updates are
needed. If no
updates are required,
please clarify.
Jun-12-2020
13:32:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Wears Glass
esInitial Entry
1.b Start Date:
Date Location User Value Reason
Jun-12-2020 13:32:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/1982Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041497
Page 202 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jun-12-2020 13:32:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Jun-12-2020 13:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:Deviated Septum - N
asal Surgery
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041498
Page 203 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Jun-12-2020 13:33:20
(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-12-2020 13:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Deviated Septum - Nasal SurgeryInitial Entry
1.c Start Date:
Date Location User Value Reason
Jun-12-2020 13:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jun-12-2020 13:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041499
Page 204 of 407
***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: 10031065 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-12-2020 13:34:14
(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-12-2020 13:34:14
(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-12-2020 13:34:14
(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-12-2020 13:34:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Jun-12-2020 13:34:14
(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-12-2020 13:34:14
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Megan
HelfData Entry:
Not ApplicableInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041500
Page 205 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe.ahelf)
7. Dose Frequency:
Date Location User Value Reason
Jun-12-2020 13:34:14
(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-12-2020 13:34:14
(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-12-2020 13:34:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041501
Page 206 of 407
***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: 10031065 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-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Jun/12/2020Initial Entry
2.a
Date Location User Value Reason
Jun-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Body System Ex
amined:GENERAL APPE
ARANCE
Result: NORMALInitial Entry
2.a Body System Examined:
Date Location User Value Reason
Jun-12-2020 13:34:36
(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-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.b
Date Location User Value Reason
Jun-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Body System Examined: SKIN
Result: NORMALInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041502
Page 207 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Body System Examined:
Date Location User Value Reason
Jun-12-2020 13:34:36
(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-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.c
Date Location User Value Reason
Jun-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Body System Examined: HEAD
Result: NORMALInitial Entry
2.c Body System Examined:
Date Location User Value Reason
Jun-12-2020 13:34:36
(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-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.d
Date Location User Value Reason
Jun-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Body System Examined: EYES
Result: NORMALInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041503
Page 208 of 407
***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: 10031065 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d Body System Examined:
Date Location User Value Reason
Jun-12-2020 13:34:36
(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-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.e
Date Location User Value Reason
Jun-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Body System Examined: EARS
Result: NORMALInitial Entry
2.e Body System Examined:
Date Location User Value Reason
Jun-12-2020 13:34:36
(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-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NORMALInitial Entry
2.f
Date Location User Value Reason
Jun-12-2020 13:34:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Body System Examined: NOSE
Result: NORMALInitial Entry
090177e196ae3d68\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041504
Page 209 of 407
***Confidential***
Hea
…[truncated]