Document text
Page 1 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041704
Page 2 of 202
***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: 10031111 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
Jul/30/2020
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041705
Page 3 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031111]
2.Birth Date: /1994
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0041706
Page 4 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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/30/2020
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041707
Page 5 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041708
Page 6 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041709
Page 7 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic
corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to study
entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041710
Page 8 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
/DeathJul/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041711
Page 9 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Migraines]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2007
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041712
Page 10 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jul/30/2020
2.Weight: [180.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [25.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041713
Page 11 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/30/2020
2.Randomization Number: [40149]
3.Randomization Group: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041714
Page 12 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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/30/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGJWD4]
5.bSample ID [BGJWD5]
5.cSample ID [BGJWD6]
5.dSample ID [BNYFL6]
5.eSample ID [BNYFL7]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041715
Page 13 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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/30/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGJWCZ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041716
Page 14 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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/30/2020 10:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041717
Page 15 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041718
Page 16 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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/20/2020
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041719
Page 17 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041720
Page 18 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041721
Page 19 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041722
Page 20 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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:
Aug/20/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57HN]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041723
Page 21 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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: Aug/20/2020 09:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041724
Page 22 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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 Sep/23/2020
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041725
Page 23 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041726
Page 24 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041727
Page 25 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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:
Sep/23/2020
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 [BPYL77]
5.bSample ID [BNWKD1]
5.cSample ID [BNWKD2]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041728
Page 26 of 202
***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: 10031111 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:
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041729
Page 27 of 202
***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: 10031111 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: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041730
Page 28 of 202
***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: 10031111 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 [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041731
Page 29 of 202
***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: 10031111 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 [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041732
Page 30 of 202
***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: 10031111 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?
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041733
Page 31 of 202
***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: 10031111 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:
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041734
Page 32 of 202
***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: 10031111 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:
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041735
Page 33 of 202
***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: 10031111 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 [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041736
Page 34 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: 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: 10031111 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 Oct/13/2020
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041737
Page 35 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041738
Page 36 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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:
Oct/13/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041739
Page 37 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041740
Page 38 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Oct/13/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: NO
4.bReaction: SWELLING
Reaction Present: NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: NO
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
5.cSymptom: HEADACHE
Symptom Present: NO
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: NO
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
5.hSymptom: CHILLS
Symptom Present: NO
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041741
Page 39 of 202
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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 :Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041742
Page 40 of 202
***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: 10031111 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: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041743
Page 41 of 202
***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: 10031111 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:
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041744
Page 42 of 202
***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: 10031111 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 [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041745
FDA-CBER-2021-5683-0041746
Page 44 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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)[psoriatic arthritis] Comments
4.Start Date Time: Sep/26/2020 06:00
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).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?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041747
Page 45 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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[2020501056]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041748
FDA-CBER-2021-5683-0041749
Page 47 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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[ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041750
Page 48 of 202
***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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041751
Page 49 of 202
***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: 10031111 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: //
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041752
Page 50 of 202
***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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041753
Page 51 of 202
***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: 10031111 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?
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041754
FDA-CBER-2021-5683-0041755
Page 53 of 202
***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: 10031111 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?
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041756
FDA-CBER-2021-5683-0041757
Page 55 of 202
***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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041758
Page 56 of 202
***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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041759
Page 57 of 202
***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: 10031111 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:
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041760
Page 58 of 202
***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: 10031111 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?
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041761
Page 59 of 202
***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: 10031111 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: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041762
Page 60 of 202
***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: 10031111 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: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041763
Page 61 of 202
***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: 10031111 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/29/2021
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041764
Page 62 of 202
***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: 10031111 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 per other protocol allowance(s) and confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041765
Page 63 of 202
***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: 10031111 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/29/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041766
Page 64 of 202
***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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041767
Page 65 of 202
***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: 10031111 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: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041768
Page 66 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10031111 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/2/2021
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041769
Page 67 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/2/2021
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041770
Page 68 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041771
Page 69 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/2/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041772
Page 70 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
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 [BPYLM9]
5.bSample ID [BNWKXD]
5.cSample ID [BNWKXF]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041773
Page 71 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
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 [BPYLM8]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041774
Page 72 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/2/2021 13:18
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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041775
Page 73 of 202
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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/22/2021
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041776
Page 74 of 202
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/22/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLPS]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041777
Page 75 of 202
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/22/2021 13:29
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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041778
Page 76 of 202
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10031111 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/2/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041779
Page 77 of 202
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Contact Outcome
1.Contact Type: Not Applicable Comments
2.Was contact made? Not Applicable Comments
3.Comments: Not Applicable
[ ]Comments
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041780
Page 78 of 202
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041781
Page 79 of 202
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041782
Page 80 of 202
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041783
Page 81 of 202
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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: [ ]
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041784
Page 82 of 202
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041785
Page 83 of 202
***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: 10031111 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 Sep/23/2020
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041786
Page 84 of 202
***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: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041787
Page 85 of 202
***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: 10031111 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
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041788
Page 86 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Dec-24-2020 07:29:44 (UTC-05:00) Eastern Time
(US & Canada)Lauren Mitchell
(pfe.lschneggenburger)PI assessed this diagnosis as possibly related to IP -
still being determined - future clinical assessments
are scheduled
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041789
Page 87 of 202
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormFeb-03-2021 13:07:06 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041790
Page 88 of 202
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-09-2021 13:08:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041791
Page 89 of 202
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-09-2021 13:08:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041792
Page 90 of 202
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-09-2021 13:08:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041793
Page 91 of 202
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Mar-09-2021 13:08:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041794
Page 92 of 202
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-09-2021 07:55:56 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
FormMar-09-2021 07:54:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
FormMar-09-2021 07:24:24 (UTC-05:00) Eastern Time
(US & Canada)Mary Criddle
(pfe mcriddle)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041795
Page 93 of 202
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-09-2021 07:55:56 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
1Mar-09-2021 07:54:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
1Mar-09-2021 07:24:24 (UTC-05:00) Eastern Time
(US & Canada)Mary Criddle
(pfe mcriddle)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041796
Page 94 of 202
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-09-2021 07:55:56 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
2Mar-09-2021 07:54:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
2Mar-09-2021 07:24:24 (UTC-05:00) Eastern Time
(US & Canada)Mary Criddle
(pfe mcriddle)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041797
Page 95 of 202
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Mar-09-2021 07:55:56 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
3Mar-09-2021 07:54:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
3Mar-09-2021 07:24:24 (UTC-05:00) Eastern Time
(US & Canada)Mary Criddle
(pfe mcriddle)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041798
Page 96 of 202
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Mar-09-2021 07:55:56 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
4Mar-09-2021 07:54:05 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
4Mar-09-2021 07:24:24 (UTC-05:00) Eastern Time
(US & Canada)Mary Criddle
(pfe mcriddle)Not Applicable
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041799
Page 97 of 202
***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: 10031111 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
Megan Helf N/A Feb-03-2021 13:02:34 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Jan-21-2021 22:05:59 (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.
Lauren Mitchell N/A Dec-08-2020 11:19:02 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Oct-20-2020 19:45:29 (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.
Megan Helf N/A Oct-13-2020 10:42:05 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041800
Page 98 of 202
***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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
N/A
Edward Walsh Approved Sep-30-2020 15:47:33 (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.
Marie Francis N/A Sep-23-2020 12:22:44 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Aug-26-2020 11:34:13 (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.
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041801
Page 99 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
Jul-30-2020 11:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-30-2020 11:31:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041802
Page 100 of 202
***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: 10031111 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
Jul-30-2020 11:31:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/30/2020Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041803
Page 101 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
Jul-30-2020 11:31:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10031111Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-30-2020 11:31:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1994Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-30-2020 11:31:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-30-2020 11:31:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOT HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-30-2020 11:31:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
WHITEInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0041804
Page 102 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
Jul-30-2020 11:31:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jul/30/2020Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041805
Page 103 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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-30-2020 11:34:38
(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 bet
ween the ages of 18 and 55 yea
rs, inclusive, 65 and 85 years, i
nclusive, or 18 and 85 years, in
clusive, at randomization (depe
ndent upon study stage)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Male or female participants between the
ages of 18 and 55 years, inclusive, 65 an
d 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent u
pon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041806
Page 104 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclusio
n Num
ber:2
Criterio
n Descr
iption:Participants who are willing a
nd able to comply with all sch
eduled visits, vaccination plan,
laboratory tests, lifestyle consi
derations, and other study proc
edures
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN02A00Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041807
Page 105 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Inclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Participants who are willing and able to
comply with all scheduled visits, vaccina
tion plan, laboratory tests, lifestyle consi
derations, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclusio
n Num
ber:3
Criteri
on Desc
ription:Healthy participants who are d
etermined by medical history,
physical examination, and clin
ical judgment of the investigat
or to be eligible for inclusion i
n the study
Criteri
on met
?:YESInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041808
Page 106 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on ID: (
For Pfi
zer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Healthy participants who are determined
by medical history, physical examination
, and clinical judgment of the investigato
r to be eligible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclusio
n Numb
er:4Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041809
Page 107 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n Descr
iption:Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the r
equirements and restrictions li
sted in the ICD and in this prot
ocol
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Capable of giving personal signed infor
med consent, which includes compliance
with the requirements and restrictions lis
ted in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-30-2020 11:34:38 ACV0PFEINFP6000 Megan Data Entry: Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041810
Page 108 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)Helf
(pfe.ahelf)Exclusi
on Nu
mber:1
Criteri
on Desc
ription:Other medical or psychiatric c
ondition incl. recent (within pa
st year) or active suicidal ideati
on/behavior/lab abnormality th
at may increase the risk of stud
y participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Other medical or psychiatric condition in
cl. recent (within past year) or active sui
cidal ideation/behavior/lab abnormality t
hat may increase the risk of study partici
pationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX01A00Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041811
Page 109 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:2
Criterion
Descripti
on:Known infection with huma
n immunodeficiency virus (
HIV), hepatitis C virus (HC
V), or hepatitis B virus (HB
V)
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX02A00Initial Entry
2.b Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Known infection with human immunode
ficiency virus (HIV), hepatitis C virus (
HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX02A00Initial Entry
2.c
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041812
Page 110 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Num
ber:3
Criterio
n Descr
iption:History of severe adverse reac
tion associated with a vaccine
and/or severe allergic reaction
(eg, anaphylaxis) to any comp
onent of the study intervention
(s)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX03A00Initial Entry
2.c Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
History of severe adverse reaction associ
ated with a vaccine and/or severe allergi
c reaction (eg, anaphylaxis) to any comp
onent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX03A00Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041813
Page 111 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Num
ber:4
Criterion Desc
ription:Receipt of medications
intended to prevent C
OVID-19
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of medications intended to preve
nt COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Megan
HelfData Entry: Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041814
Page 112 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe.ahelf) Exclusio
n Numb
er:8
Criterio
n Descri
ption:Immunocompromised individ
uals with known or suspected
immunodeficiency, as determi
ned by history and/or laborato
ry/physical examination
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Immunocompromised individuals with k
nown or suspected immunodeficiency, as
determined by history and/or laboratory/
physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041815
Page 113 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Num
ber:10
Criterio
n Descri
ption:Bleeding diathesis or conditio
n associated with prolonged bl
eeding that would, in the opini
on of the investigator, contrain
dicate intramuscular injection
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00Initial Entry
2.f Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Bleeding diathesis or condition associate
d with prolonged bleeding that would, in
the opinion of the investigator, contraind
icate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX10A00Initial Entry
2.g
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041816
Page 114 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Numb
er:11
Criterion Descri
ption:Women who are pre
gnant or breastfeedi
ng
Criterion met?: NO
Criterion ID: (Fo
r Pfizer use only)
:EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Women who are pregnant or breastfeedi
ngInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Num
ber:12Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041817
Page 115 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion Descr
iption:Previous vaccination
with any coronavirus
vaccine
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Previous vaccination with any coronavir
us vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive immu
nosuppressive therapy, such
as cytotoxic agents or syste
mic corticosteroids
Criterion
met?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041818
Page 116 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion
ID: (For P
fizer use o
nly):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Subjects who receive immunosuppressiv
e therapy, such as cytotoxic agents or sys
temic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Num
ber:15
Criterio
n Descri
ption:Receipt of blood/plasma prod
ucts or immunoglobulin, from
60 days before study intervent
ion administration or planned
receipt throughout the study
Criterio
n met?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041819
Page 117 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of blood/plasma products or im
munoglobulin, from 60 days before stud
y intervention administration or planned
receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX14A01Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041820
Page 118 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
2.k
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numbe
r:16
Criterio
n Descri
ption:Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study par
ticipation
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX15A01Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041821
Page 119 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.k Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Participation in other studies involving s
tudy intervention within 28 days prior to
study entry and/or during study participa
tionInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in ot
her studies involving study
intervention containing lipi
d nanoparticles
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX16A01Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041822
Page 120 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.l Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Previous participation in other studies in
volving study intervention containing lip
id nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfizer
employees directly involved in
the conduct of the study, site st
aff otherwise supervised by the
investigator, and their respecti
ve family members
Criteri
on met
?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041823
Page 121 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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.m Exclusion Number:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Investigator site staff or Pfizer employee
s directly involved in the conduct of the
study, site staff otherwise supervised by
the investigator, and their respective fam
ily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-30-2020 11:34:38
(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
Jul-30-2020 11:34:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX21A01Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041824
Page 122 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
Jul-30-2020 11:34:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jul/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-30-2020 11:34:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jul-30-2020 11:34:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041825
Page 123 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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-30-2020 11:37:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Migraines
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/20
07Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-30-2020 11:37:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020 11:37:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
MigrainesInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-30-2020 11:37:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-30-2020 11:37:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.b
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041826
Page 124 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jul-30-2020 11:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Seasonal Allergi
es
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Jul-30-2020 11:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020 11:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-30-2020 11:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-30-2020 11:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041827
Page 125 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jul/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
180.0Initial Entry
3. Unit:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.1Initial Entry
7.a
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041828
Page 126 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Location:: FOREHEADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jul-30-2020 11:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
FOREHEADInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041829
Page 127 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jul-30-2020 11:36:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jul/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jul-31-2020 10:49:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
40149Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041830
Page 128 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020 11:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 11:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020 11:51:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 11:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jul-30-2020 11:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020 11:51:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWD4Initial Entry
5.a Sample ID
Date Location User Value Reason
Jul-30-2020 11:51:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWD4Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041831
Page 129 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b
Date Location User Value Reason
Jul-30-2020 11:51:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWD5Initial Entry
5.b Sample ID
Date Location User Value Reason
Jul-30-2020 11:51:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWD5Initial Entry
5.c
Date Location User Value Reason
Jul-30-2020 11:52:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWD6Initial Entry
5.c Sample ID
Date Location User Value Reason
Jul-30-2020 11:52:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWD6Initial Entry
5.d
Date Location User Value Reason
Jul-30-2020 11:52:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BNYFL6Initial Entry
5.d Sample ID
Date Location User Value Reason
Jul-30-2020 11:52:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BNYFL6Initial Entry
5.e
Date Location User Value Reason
Jul-30-2020 11:52:15
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Madison
MurphyData Entry:
Sample ID: BNYFL7Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041832
Page 130 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe mmurphy)
5.e Sample ID
Date Location User Value Reason
Jul-30-2020 11:52:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BNYFL7Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041833
Page 131 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-30-2020 11:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-30-2020 11:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-30-2020 11:51:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 11:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jul-30-2020 11:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Jul/30/2020Initial Entry
5.a
Date Location User Value Reason
Jul-30-2020 11:51:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWCZInitial Entry
5.a Sample ID
Date Location User Value Reason
Jul-30-2020 11:51:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWCZInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041834
Page 132 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jul/30/2020 10:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041835
Page 133 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jul-30-2020 11:35:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041836
Page 134 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jul-30-2020 11:34:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041837
Page 135 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
Aug-20-2020 11:43:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041838
Page 136 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic symptom
s present on the last day the Sub
ject Diary was completed?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041839
Page 137 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041840
Page 138 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041841
Page 139 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041842
Page 140 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041843
Page 141 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4. Injection Site Body Side:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041844
Page 142 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-20-2020 11:46:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041845
Page 143 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 11:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Aug/20/2020Initial Entry
2.a
Date Location User Value Reason
Aug-20-2020 11:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Location:: FOREHEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 11:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-20-2020 11:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-20-2020 11:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 11:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
FOREHEADInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041846
Page 144 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 11:45:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 11:45:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 13:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 11:45:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-20-2020 11:45:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 13:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP57HNInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 13:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BP57HNInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041847
Page 145 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Aug/20/2020 09:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041848
Page 146 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-20-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041849
Page 147 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
Sep-23-2020 12:22:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Sep/23/2020Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041850
Page 148 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041851
Page 149 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041852
Page 150 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041853
Page 151 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041854
Page 152 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041855
Page 153 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4. Injection Site Body Side:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pr
esent on the last day the Subje
ct Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041856
Page 154 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe.mfrancis)Data Entry:
NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041857
Page 155 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 12:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 12:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 14:23:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 12:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-23-2020 12:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Marie Francis
(pfe mfrancis)Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 14:23:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BPYL77Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 14:23:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BPYL77Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041858
Page 156 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b
Date Location User Value Reason
Sep-23-2020 14:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BNWKD1Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 14:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BNWKD1Initial Entry
5.c
Date Location User Value Reason
Sep-23-2020 14:23:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BNWKD2Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 14:23:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BNWKD2Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041859
Page 157 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: DATE OF VISIT - eCRF Audit Trail History
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: 10031111 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
Oct-15-2020 05:34:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe nairr29)Query 1: Deleted No other assessments
are performed at this
visit.
Oct-14-2020 15:13:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered. Please
check whether other
assessments are
performed at this visit.
Oct-13-2020 10:42:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Data Entry:
Oct/13/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Feb-22-2021 15:59:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry: Changed Information
Oct-14-2020 15:13:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041860
Page 158 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Assessments
Date Location User Value Reason
Feb-22-2021 23:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Pramod Margaj
(pfemargap03)Query 4: Closed Response satisfies
query
Feb-22-2021 15:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf (pfe.ahelf) Query 4: Answered Changed data per query
Feb-22-2021 12:57:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cheryl Haseman
(pfe hasemc)Query 4: Opened 'Erroneous Visit' is
marked in DOV CRF
but data is present in
this CRF. Please untick
erroneous visit button
in DOV CRF *if* visit
occurred. Otherwise,
add form-level
comment = NOT
APPLICABLE/NOT
DONE to forms
containing data within
this visit.
Dec-08-2020 11:22:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 3: Deleted Close Auto Query
Dec-08-2020 11:19:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 3: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Dec-08-2020 11:19:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
CONTACT OUTCOMEInitial Entry
Oct-14-2020 15:13:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 2: Deleted Close Auto Query
Oct-14-2020 15:13:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf (pfe.ahelf) Data Entry: Changed Information
Oct-14-2020 15:13:13 ACV0PFEINFP6000 auto query (autoquery) Query 2: Candidate 'Contact Outcome is
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041861
Page 159 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Oct-13-2020 10:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 1: Deleted Close Auto Query
Oct-13-2020 10:42:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Oct-13-2020 10:42:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf (pfe.ahelf) Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041862
Page 160 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Contact Type:
Date Location User Value Reason
Dec-08-2020 11:22:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
Oct-14-2020 15:13:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Oct-13-2020 10:42:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 3: Deleted Close Auto Query
Dec-08-2020 11:23:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 2: Closed Close Auto Query
Dec-08-2020 11:23:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
YES
Date of Contact:
Oct/13/2020
Contact Outcome:
VISIT ARRANGEDTranscription Error
Dec-08-2020 11:22:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 3: Candidate Contact Outcome' is
selected as 'VISIT
ARRANGED' but no
'VITAL SIGNS'
and/or
'UNPLANNED
ASSESSMENT OF
LOCAL REACTION'
form(s) is/are entered.
Please review and
update as appropriate.
Dec-08-2020 11:22:29 ACV0PFEINFP6000 auto query (autoquery) Query 2: Opened Date of Contact
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041863
Page 161 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)13/Nov/2020 is not
equal to the Date of
Visit 13/Oct/2020
within same
unplanned visit.
Please review and
update as appropriate.
Dec-08-2020 11:22:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
YES
Date of Contact:
Nov/13/2020
Contact Outcome:
VISIT ARRANGEDInitial Entry
Oct-14-2020 15:13:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf (pfe.ahelf) Data Entry: Changed Information
Oct-14-2020 10:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swapna Varikuti
(pfe.variks)Query 1: Closed Query to be raised
post sanpshot
Oct-14-2020 04:57:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swapna Varikuti
(pfe.variks)Query 1: Opened PDQ : Contact
Outcome' is selected
as 'VISIT
ARRANGED' but no
'VITAL SIGNS'
and/or
'UNPLANNED
ASSESSMENT OF
LOCAL REACTION'
form(s) is/are entered.
Please review and
update as appropriate.
Oct-13-2020 10:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 1: Candidate Contact Outcome' is
selected as 'VISIT
ARRANGED' but no
'VITAL SIGNS'
and/or
'UNPLANNED
ASSESSMENT OF
LOCAL REACTION'
form(s) is/are entered.
Please review and
update as appropriate.
Oct-13-2020 10:42:28
(UTC-05:00) EasternACV0PFEINFP6000 Megan Helf (pfe.ahelf) Data Entry:
YESInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041864
Page 162 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) Date of Contact:
Oct/13/2020
Contact Outcome:
VISIT ARRANGED
3. Comments:
Date Location User Value Reason
Dec-08-2020 11:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry: Transcription Error
Dec-08-2020 11:22:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Patient was seen in the office on 1
3NOV2020.Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041865
Page 163 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Feb-23-2021 07:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Deshmukh
(pfe.deshma24)Query 1: Closed Visit is not marked as
Erroneous
Feb-22-2021 15:59:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf (pfe.ahelf) Query 1: Answered Changed data per query
Feb-22-2021 12:58:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cheryl Haseman
(pfe hasemc)Query 1: Opened 'Erroneous Visit' is
marked in DOV CRF
but data is present in
this CRF. Please untick
erroneous visit button
in DOV CRF *if* visit
occurred. Otherwise,
add form-level
comment = NOT
APPLICABLE/NOT
DONE to forms
containing data within
this visit.
Dec-08-2020 11:24:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Oct/13/2020Initial Entry
2.a
Date Location User Value Reason
Dec-08-2020 11:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-08-2020 11:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
1Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041866
Page 164 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Temperature:
Date Location User Value Reason
Dec-08-2020 11:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-08-2020 11:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-08-2020 11:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
FOREHEADInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041867
Page 165 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-23-2021 09:56:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
Feb-22-2021 15:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf (pfe.ahelf) Query 1: Answered Changed data per query
Feb-22-2021 12:58:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cheryl Haseman
(pfe hasemc)Query 1: Opened 'Erroneous Visit' is
marked in DOV CRF
but data is present in
this CRF. Please untick
erroneous visit button
in DOV CRF *if* visit
occurred. Otherwise,
add form-level
comment = NOT
APPLICABLE/NOT
DONE to forms
containing data within
this visit.
Dec-08-2020 11:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Oct/13/2020Initial Entry
2. Injection Site Location
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
LEFTInitial Entry
4.a
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041868
Page 166 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Reaction:: REDNESS
Reaction Present:: NOInitial Entry
4.a Reaction:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
REDNESSInitial Entry
4.a Reaction Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Reaction:: SWELLING
Reaction Present:: NOInitial Entry
4.b Reaction:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
SWELLINGInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:: PAIN AT INJECTI
ON SITEInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041869
Page 167 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Symptom Pr
esent::NO
5.a Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.a Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:: FATIGUE/TIRE
DNESS
Symptom Pre
sent::NOInitial Entry
5.b Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
FATIGUE/TIREDNESSInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:: HEADACH
EInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041870
Page 168 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Symptom Present:
:NO
5.c Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
HEADACHEInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.d
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:: VOMITING
Symptom Present:: NOInitial Entry
5.d Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
VOMITINGInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.e
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:: DIARRHEA
Symptom Present:: NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041871
Page 169 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
DIARRHEAInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.f
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:
:NEW OR WORSEN
ED MUSCLE PAIN
Symptom
Present::NOInitial Entry
5.f Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.g
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:: NEW OR WORSEN
ED JOINT PAIN
Symptom
Present::NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041872
Page 170 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.g Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
5.h
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Symptom:: CHILLS
Symptom Present:: NOInitial Entry
5.h Symptom:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
CHILLSInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Dec-08-2020 11:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041873
Page 171 of 202
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 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
Sep-24-2020 10:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe mcriddle)Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020 10:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020 10:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe mcriddle)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041874
Page 172 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Form Created
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041875
Page 173 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021 15:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 5: Closed closing a query on a
deleted AE
Feb-24-2021 14:29:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Query 5: Answered start date faxed to
safety
Feb-22-2021 20:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 5: Opened CLINICAL - please
submit a SAE safety
update reporting the
start date of
leflunomide, if known
Jan-22-2021 22:48:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 4: Closed Response satisfies
query
Jan-22-2021 13:55:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Query 4: Answered psoriatic arthritis
remained the
diagnosis on the
rheumatology follow
up.
Jan-21-2021 00:04:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 4: Opened CLINICAL Event
term is Psoriatic
Arthritis; however,
SAE report states that
Rheumatologist
considered both
Reactive Arthritis &
PSA. Please confirm
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041876
Page 174 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
PSA remained the
diagnosis on Rheum
followup
Jan-21-2021 00:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Closed rewording query
Jan-20-2021 23:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Opened CLINICAL Event
term is Psoriatic
Arthritis; however,
SAE report states that
Rheumatologist
diagnosis was
Reactive Arthritis.
Please review event
term, and update in
AE/SAE if
appropriate
Dec-24-2020 09:02:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Closed clin: Thank you. Can
you address PI
rationale for
assessment as
'possibly related'
Dec-24-2020 07:30:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Query 1: Answered Added a level
comment to address
"relatedness"
Dec-22-2020 22:15:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Dec-22-2020 13:23:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Reissued:Opened clinical: Thank you.
Pls address biological
basis for assessment
as 'related'
Dec-22-2020 11:37:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Query 1: Answered No prior history
known - this is a new
diagnosis. Subject
awaiting treatment.
Dec-21-2020 14:47:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Query 2: Answered subject has had no
iron studies
Dec-21-2020 11:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical Thank you
for the extensive SAE
lab reporting section;
please confirm if
subject has had iron
studies (young M with
asymmetric small jt
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041877
Page 175 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
arthritis).
Dec-21-2020 11:14:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sian Jones
(pfe.jones111)Query 1: Opened clin: pls advise on
biological basis for
determination as
'related', confirm this
is a new diagnosis and
advise on what
treatment subject has
received. Confirm no
prior hx of joint pains
or psoriasis or update
MedHx CRF
accordingly Thanks
Dec-18-2020 12:30:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
psoriatic arthritisNew Information
Oct-14-2020 15:23:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan Helf (pfe.ahelf) Data Entry:
TenosynovitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Sep/26/2020 06:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
2Initial Entry
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).
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041878
Page 176 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Dec-22-2020 05:38:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 12:30:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE psoriatic
arthritis: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-18-2020 12:27:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Tenosynovitis:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-18-2020 12:27:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe mcriddle)Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death
?
NO
Did this serious event require or prol
ong hospitalization?
NO
Did this serious event result in persis
tent or significant disability/incapacit
y?
NO
Is this serious event life threatening?
NO
Other medically important serious ev
ent
YESNew Information
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041879
Page 177 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-21-2020 11:30:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Dec-21-2020 10:02:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-21-2020 10:02:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe mcriddle)Data Entry:
RELATEDNew Information
Dec-18-2020 13:09:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL Event
Relationship to study
treatment is NOT
RELATED; however,
SAE report has
RELATED. Please
review, harmonize
reporting, and update
in the appropriate
location.
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan Helf
(pfe.ahelf)Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041880
Page 178 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOT RECOVERED/NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020 15:23:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-22-2020 05:38:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020501056Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041881
Page 179 of 202
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
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: 10031111 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
Feb-03-2021 13:02:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jan/29/2021Initial Entry
090177e196ae3d69\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041882
Page 180 of 202
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
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: 10031111 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2
…[truncated]