Document text
Page 1 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041906
Page 2 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041907
Page 3 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031113]
2.Birth Date: /1946
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:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0041908
Page 4 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041909
Page 5 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041910
Page 6 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041911
Page 7 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041912
Page 8 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041913
Page 9 of 409
***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: 10031113 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: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041914
Page 10 of 409
***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: 10031113 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:[Osteoarthritis]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2017
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Interstitial Lung Disease]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041915
Page 11 of 409
***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: 10031113 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: [158.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [22.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041916
Page 12 of 409
***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: 10031113 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: [220530]
3.Randomization Group: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041917
Page 13 of 409
***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: 10031113 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 [BGJWDX]
5.bSample ID [BGJWDY]
5.cSample ID [BGJWDZ]
5.dSample ID [BKDYVG]
5.eSample ID [BKDYVH]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041918
Page 14 of 409
***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: 10031113 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 [BGJWDB]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041919
Page 15 of 409
***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: 10031113 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 13:55
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041920
Page 16 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041921
Page 17 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041922
Page 18 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041923
Page 19 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041924
Page 20 of 409
***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: 10031113 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: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041925
Page 21 of 409
***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: 10031113 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 [BP57HR]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041926
Page 22 of 409
***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: 10031113 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 13:04
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041927
Page 23 of 409
***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: 10031113 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/21/2020
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041928
Page 24 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041929
Page 25 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041930
Page 26 of 409
***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: 10031113 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/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYL6L]
5.bSample ID [BNWKBS]
5.cSample ID [BNWKBT]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041931
Page 27 of 409
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 10031113 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/26/2021
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041932
Page 28 of 409
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 10031113 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[same as convalescent blood]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041933
Page 29 of 409
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L 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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041934
Page 30 of 409
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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 [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041935
Page 31 of 409
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L 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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041936
Page 32 of 409
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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 [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041937
Page 33 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10031113 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/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041938
Page 34 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/15/2020
2.Date of First Symptom Started: Oct/14/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/4/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041939
Page 35 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [weakness]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041940
Page 36 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/14/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041941
Page 37 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/14/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041942
Page 38 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10031113 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[swab obtained on site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041943
Page 39 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 10031113 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:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYL9X]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041944
Page 40 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041945
FDA-CBER-2021-5683-0041946
Page 42 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Oct/14/2020
4.Ongoing? NO
Discharge Date:
Oct/16/2020Comments
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041947
FDA-CBER-2021-5683-0041948
Page 44 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? [ ] Comments
2.Concomitant Non-drug Treatment
Pre-specified:Comments
3.Treatment: Comments
4.Treatment: [ ] Comments
5.Start Date: // Comments
6.Ongoing? Comments
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041949
Page 45 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[severe sepsis]
Date of Diagnosis:
Oct/14/2020
3.Toxicity Grade: 4
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041950
FDA-CBER-2021-5683-0041951
Page 47 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041952
Page 48 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category f
or Lab TestVendor NameCollect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
1.CLINICAL
CHEMIST
RY Rochester General Hospital La
b 1425 Portland Ave. Rocheste
r NY 14621 Oct/14/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329 C Reactive Pro
tein_PX329 14.
1
30 Alanine Amin
otransferase_P
X30 24
28 Aspartate Ami
notransferase_
PX28 40
35 Alkaline Phosp
hatase_PX35 96
21 Bilirubin_PX2
1 .9
47 Blood Urea Nit
rogen_PX47 16
48 Creatinine_PX
48 .9 Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041953
Page 49 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Rochester General Hospital Lab 1425 Portland Ave. Rochester NY 14621]
3.Collection Date: Oct/14/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [14.1]
Not Done:
LNMT Low
[0.0]
High
[10.0]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [24]
Not Done:
LNMT Low
[10]
High
[49]
Unit
U/L
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041954
Page 50 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [40]
Not Done:
LNMT Low
[7]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [96]
Not Done:
LNMT Low
[46]
High
[116]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [.9]
Not Done:
LNMT Low
[.3]
High
[1.2]
Unit
mg/dL
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041955
Page 51 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [16]
Not Done:
LNMT Low
[8]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [.9]
Not Done:
LNMT Low
[.7]
High
[1.2]
Unit
mg/dL
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041956
Page 52 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
1.HEMATOL
OGY Rochester General Hospital 142
5 Portland Ave Rochester NY 1
4621 Oct/14/2
020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1 Hemoglob
in_PX1 16.1
2 Hematocri
t_PX2 48
3 Erythrocyt
es_PX3 4.82
5 Platelets_P
X5 179
7 Leukocyte
s_PX7 4.5
608 Neutrophil
s_PX608 85%
609 Eosinophil
s_PX609 0%
612 Monocytes
_PX612 0%
610 Basophils_
PX610 0%
611 Lymphocy
tes_PX611
.2 Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041957
Page 53 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Queries, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Rochester General Hospital 1425 Portland Ave Rochester NY 14621]
3.Collection Date: Oct/14/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [16.1]
Not Done:
LNMT Low
[13]
High
[18]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [48]
Not Done:
LNMT Low
[40]
High
[52]
Unit
%
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041958
Page 54 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Queries, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.82]
Not Done:
LNMT Low
[4.40]
High
[6.20]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [179]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [4.5]
Not Done:
LNMT Low
[4.0]
High
[11.0]
Unit
10^3/uL
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041959
Page 55 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Queries, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [85%]
Not Done:
LNMT Low
[45]
High
[75]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0%]
Not Done:
LNMT Low
[0]
High
[5]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0%]
Not Done:
LNMT Low
[0]
High
[15]
Unit
%
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041960
Page 56 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Queries, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0%]
Not Done:
LNMT Low
[0]
High
[3]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [.2]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041961
FDA-CBER-2021-5683-0041962
Page 58 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [80]
Diastolic: [53]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [103]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041963
FDA-CBER-2021-5683-0041964
Page 60 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041965
FDA-CBER-2021-5683-0041966
Page 62 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Oct/15/2020 23:51
2.Arterial Blood Gases PaO2
(mmHg):[98]
3.FiO2 (Fraction of Inhaled Oxygen): Unknown
[ ]Comments
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041967
Page 63 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.[ ] [ ] Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041968
Page 64 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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.Start Date: //
6.Ongoing?
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041969
Page 65 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of Asse
ssmentLocation of As
sessmentImaging M
ethodOverall AssessmentForm Instanc
e
1.Oct/14/2020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
increased retrocardiac airspace opacity of left lower z
one, concerning for pneumonia.
Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041970
Page 66 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Oct/14/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[increased retrocardiac airspace opacity of left lower zone, concerning for
pneumonia.]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041971
Page 67 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10031113 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/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041972
Page 68 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/13/2021
2.Date of First Symptom Started: Jan/11/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041973
Page 69 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.aSymptoms - Other Text: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041974
Page 70 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descriptio
nDevice TypeForm Insta
nce
1. DELETED Jan/11/20
21 SWABBED
MATERIAL
NASOPHARY
NX SEVERE ACUTE RESP S
YNDROME CORONAVIR
US 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041975
Page 71 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/11/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041976
Page 72 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10031113 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[swab pfe]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041977
Page 73 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: 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: 10031113 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:
Jan/11/2021
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 [BPYLJP]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041978
Page 74 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041979
FDA-CBER-2021-5683-0041980
Page 76 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/11/2021
4.Ongoing? NO
Discharge Date:
Jan/13/2021
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041981
FDA-CBER-2021-5683-0041982
Page 78 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041983
FDA-CBER-2021-5683-0041984
Page 80 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041985
Page 81 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041986
Page 82 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041987
Page 83 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041988
Page 84 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041989
FDA-CBER-2021-5683-0041990
Page 86 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - COVID
Form Version: 17-Jul-2020 21:53 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041991
FDA-CBER-2021-5683-0041992
Page 88 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041993
FDA-CBER-2021-5683-0041994
Page 90 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041995
Page 91 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041996
Page 92 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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.Start Date: //
6.Ongoing?
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041997
FDA-CBER-2021-5683-0041998
Page 94 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0041999
Page 95 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/18/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 10031113 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 Nov/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042000
Page 96 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/18/2020Form: 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: 10031113 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:
Nov/18/2020
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 [BPYLC7]
5.bSample ID [BNWKMP]
5.cSample ID [BNWKKP]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042001
Page 97 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 10031113 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/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042002
Page 98 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/26/2021Form: 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: 10031113 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/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[low draw]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLTD]
5.bSample ID [BVR36N]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042003
Page 99 of 409
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042004
Page 100 of 409
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042005
Page 101 of 409
***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: 10031113 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042006
Page 102 of 409
***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: 10031113 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: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042007
Page 103 of 409
***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: 10031113 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:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042008
Page 104 of 409
***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: 10031113 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 [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042009
Page 105 of 409
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 worsening of interstiti
al lung disease Oct/17/2020 U
NK:UNK YES Repeating
Pages
2. DELETED ADVERSE
EVENT 2 community acquired p
neumonia Oct/14/2020 U
NK:UNK YES Repeating
Pages
3. ADVERSE
EVENT 3 positive autoantibody
status Oct/20/2020 U
NK:UNK YES Repeating
Pages
4. ADVERSE
EVENT 4 respiratory failure Jan/11/2021 U
NK:UNK YES Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042010
Page 106 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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)[worsening of interstitial lung disease]
4.Start Date Time: Oct/17/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[worsening of interstitial lung disease]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042011
Page 107 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020409757]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042012
Page 108 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[community acquired pneumonia ]
4.Start Date Time: Oct/14/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042013
Page 109 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[community acquired pneumonia ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042014
Page 110 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[positive autoantibody status]
4.Start Date Time: Oct/20/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[possible scleroderma]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042015
Page 111 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042016
Page 112 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[respiratory failure]
4.Start Date Time: Jan/11/2021 UNK:UNK
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?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042017
Page 113 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[interstitial lung disease]
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021026385]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042018
Page 114 of 409
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042019
Page 115 of 409
***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: 10031113 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[ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042020
Page 116 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart Dat
eForm Instan
ce
1. DELETED Not Applicab
le Not Appli
cable Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042021
Page 117 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042022
Page 118 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. DELETED 1 CORTICOSTE
ROIDS NO Solu-MEDR
OL 60 Repeating
Pages
2. DELETED 250 Repeating
Pages
3. DELETED 3 CORTICOSTE
ROIDS NO prednisone 60 Repeating
Pages
4. DELETED 4 CORTICOSTE
ROIDS NO prednisone 50 Repeating
Pages
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042023
Page 119 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Solu-MEDROL ]
5.Dose: [60]
6.Dose Unit: mg
7.Dose Frequency: BID
8.Route: INTRAVENOUS
9.Start Date: Oct/22/2020
10.Ongoing? NO
End Date:
Oct/24/2020
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042024
Page 120 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: [250]
6.Dose Unit: mg
7.Dose Frequency: BID
8.Route: INTRAVENOUS
9.Start Date: Oct/24/2020
10.Ongoing? NO
End Date:
Oct/26/2020
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042025
Page 121 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [3]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[prednisone ]
5.Dose: [60]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Oct/27/2020
10.Ongoing? NO
End Date:
Nov/2/2020
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042026
Page 122 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [4]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[prednisone ]
5.Dose: [50]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Oct/27/2020
10.Ongoing? YES
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042027
FDA-CBER-2021-5683-0042028
Page 124 of 409
***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: 10031113 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?
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042029
FDA-CBER-2021-5683-0042030
Page 126 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042031
Page 127 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042032
Page 128 of 409
***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: 10031113 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:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042033
Page 129 of 409
***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: 10031113 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?
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042034
Page 130 of 409
***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: 10031113 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: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042035
Page 131 of 409
***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: 10031113 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: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042036
Page 132 of 409
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042037
Page 133 of 409
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042038
Page 134 of 409
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10031113 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 [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042039
Page 135 of 409
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10031113 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 [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042040
Page 136 of 409
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
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: 10031113 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/13/2021
2.Erroneous Visit
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042041
Page 137 of 409
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042042
Page 138 of 409
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042043
Page 139 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042044
Page 140 of 409
***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: 10031113 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: [ ]
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042045
Page 141 of 409
***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: 10031113 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/21/2020
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042046
Page 142 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042047
Page 143 of 409
***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: 10031113 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
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042048
Page 144 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormFeb-02-2021 14:03:54 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)symptoms not new or worsening on 04Dec2020
however not fully resolved.
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042049
Page 145 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Dec-01-2020 08:37:17 (UTC-05:00) Eastern
Time (US & Canada)Lauren Mitchell
(pfe.lschneggenburger)Subjects admission was from 14OCT2020 -
16OCT2020
4Nov-30-2020 12:11:16 (UTC-05:00) Eastern
Time (US & Canada)Lauren Mitchell
(pfe.lschneggenburger)Subjects first admission was from
14OCT2020 - 16OCT2020
Subjects second admission was from
17OCT2020 - 26OCT2020
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042050
Page 146 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormMar-12-2021 07:24:42 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)
FormMar-12-2021 07:24:13 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042051
Page 147 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Mar-12-2021 07:24:42 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)
1Mar-12-2021 07:24:13 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042052
Page 148 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Mar-12-2021 07:24:42 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)
2Mar-12-2021 07:24:13 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042053
Page 149 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Mar-12-2021 07:24:42 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)
3Mar-12-2021 07:24:13 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042054
Page 150 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
4Mar-12-2021 07:24:42 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)
4Mar-12-2021 07:24:13 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042055
Page 151 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
5Mar-12-2021 07:24:42 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)
5Mar-12-2021 07:24:13 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042056
Page 152 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
6Mar-12-2021 07:24:42 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)
6Mar-12-2021 07:24:13 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042057
Page 153 of 409
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Dec-01-2020 08:36:17 (UTC-05:00) Eastern
Time (US & Canada)Lauren Mitchell
(pfe.lschneggenburger)Unknown
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042058
Page 154 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Jan-20-2021 11:45:45 (UTC-05:00) Eastern
Time (US & Canada)Mary Criddle
(pfe mcriddle)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042059
Page 155 of 409
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Jan-20-2021 11:46:49 (UTC-05:00) Eastern
Time (US & Canada)Mary Criddle
(pfe mcriddle)Not Applicable
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042060
Page 156 of 409
***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: 10031113 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
Mary Criddle N/A Jan-26-2021 12:15:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Jan-21-2021 21:33:20 (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.
Madison
Murphy N/A Nov-18-2020 10:12:11 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Nov-17-2020 07:21:59 (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.
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042061
Page 157 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mary Criddle N/A Nov-16-2020 08:47:42 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Nov-13-2020 13:25:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle N/A Nov-04-2020 08:48:55 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Nov-02-2020 07:50:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle N/A Oct-27-2020 14:42:04 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042062
Page 158 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Edward Walsh Approved Oct-27-2020 11:10:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle N/A Oct-23-2020 14:33:32 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Oct-23-2020 09:09:52 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle N/A Oct-22-2020 12:49:43 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Oct-20-2020 19:49:42 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042063
Page 159 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle N/A Oct-15-2020 10:50:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Sep-23-2020 16:43:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle N/A Sep-21-2020 09:06:00 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh Approved Aug-26-2020 11:35:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042064
Page 160 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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.
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042065
Page 161 of 409
***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: 10031113 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 13:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)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 13:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042066
Page 162 of 409
***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: 10031113 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 13:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
OBTAINED
Date Written Consent Obtained
Jul/30/2020Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042067
Page 163 of 409
***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: 10031113 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 13:38:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10031113Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-30-2020 13:38:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-30-2020 13:39:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-30-2020 13:39:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-30-2020 13:39:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
WHITEInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0042068
Page 164 of 409
***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: 10031113 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 15:52:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jul/30/2020Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042069
Page 165 of 409
***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: 10031113 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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclus
ion N
umber
:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65 a
nd 85 years, inclusive, or 1
8 and 85 years, inclusive, a
t randomization (dependen
t upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at randoInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042070
Page 166 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
mization (dependent upon study sta
ge)
1.a Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vacc
ination plan, laboratory te
sts, lifestyle consideration
s, and other study procedu
res
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042071
Page 167 of 409
***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: 10031113 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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Participants who are willing and ab
le to comply with all scheduled visi
ts, vaccination plan, laboratory tests
, lifestyle considerations, and other
study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042072
Page 168 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Healthy participants who
are determined by medical
history, physical examinati
on, and clinical judgment
of the investigator to be el
igible for inclusion in the
study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042073
Page 169 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Inclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgment
of the investigator to be eligible for
inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042074
Page 170 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Capable of giving persona
l signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the
ICD and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042075
Page 171 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Inclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Capable of giving personal signed i
nformed consent, which includes c
ompliance with the requirements an
d restrictions listed in the ICD and i
n this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042076
Page 172 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active s
uicidal ideation/behavior/l
ab abnormality that may in
crease the risk of study par
ticipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Other medical or psychiatric condit
ion incl. recent (within past year) or
active suicidal ideation/behavior/la
b abnormality that may increase the
risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042077
Page 173 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatitis
B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX02A00Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042078
Page 174 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Known infection with human immu
nodeficiency 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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:3Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042079
Page 175 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyla
xis) to any component of t
he study intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042080
Page 176 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
History of severe adverse reaction a
ssociated with a vaccine and/or sev
ere allergic reaction (eg, anaphylaxi
s) to any component of the study in
tervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Nu
mber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:NOInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042081
Page 177 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion ID:
(For Pfizer u
se only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042082
Page 178 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Immunocompromised ind
ividuals with known or su
spected immunodeficienc
y, as determined by histor
y and/or laboratory/physi
cal examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX08A00
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042083
Page 179 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Immunocompromised individuals
with known or suspected immunod
eficiency, as determined by history
and/or laboratory/physical examina
tionInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042084
Page 180 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with prol
onged bleeding that woul
d, in the opinion of the in
vestigator, contraindicate i
ntramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042085
Page 181 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding tha
t would, in the opinion of the invest
igator, contraindicate intramuscular
injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:NOInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042086
Page 182 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Women who are pregnant or breastf
eedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any corona
virus vaccineInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042087
Page 183 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Previous vaccination with any coro
navirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numbe
r:13Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042088
Page 184 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive ther
apy, such as cytotoxic a
gents or systemic cortic
osteroids
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Subjects who receive immunosuppr
essive therapy, such as cytotoxic ag
ents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX13A01Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042089
Page 185 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.j
Date Location User Value Reason
Jul-30-2020 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma p
roducts or immunoglobuli
n, from 60 days before stu
dy intervention administra
tion or planned receipt thr
oughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX14A01Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042090
Page 186 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.j Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Receipt of blood/plasma products o
r immunoglobulin, from 60 days be
fore study intervention administrati
on or planned receipt throughout th
e studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX14A01Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042091
Page 187 of 409
***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: 10031113 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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descr
iption:Participation in other stu
dies involving study inte
rvention within 28 days
prior to study entry and/
or during study participa
tion
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042092
Page 188 of 409
***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: 10031113 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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Participation in other studies invol
ving study intervention within 28 d
ays prior to study entry and/or duri
ng study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Exclusio
n Numbe
r:17
Criterion
Descripti
on:Previous participation i
n other studies involvin
g study intervention co
ntaining lipid nanoparti
clesInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042093
Page 189 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Previous participation in other stud
ies involving study intervention co
ntaining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(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 15:52:48
(UTC-05:00) EasternACV0PFEINFP6000 Megan
HelfData Entry:
Exclus22Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042094
Page 190 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf) ion Nu
mber:
Criter
ion De
scripti
on:Investigator site staff or Pf
izer employees directly in
volved in the conduct of t
he study, site staff otherwi
se supervised by the invest
igator, and their respective
family members
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042095
Page 191 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.m Exclusion Number:
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Investigator site staff or Pfizer emp
loyees directly involved in the con
duct of the study, site staff otherwis
e supervised by the investigator, an
d their respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jul-30-2020 15:52:48
(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 15:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
EX21A01Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042096
Page 192 of 409
***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: 10031113 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 15:53:07
(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 15:53:07
(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 15:53:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042097
Page 193 of 409
***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: 10031113 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 16:03:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Osteoarthritis
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jul-30-2020 16:03:53
(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 16:03:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
OsteoarthritisInitial Entry
1.a Start Date:
Date Location User Value Reason
Jul-30-2020 16:03:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jul-30-2020 16:03:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.b
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042098
Page 194 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jul-30-2020 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:Anxiety
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Jul-30-2020 16:04:12
(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 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Jul-30-2020 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jul-30-2020 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Jul-30-2020 16:11:03
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number 3Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042099
Page 195 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) :
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/20
17
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Jul-30-2020 16:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jul-30-2020 16:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Seasonal AllergiesInitial Entry
1.c Start Date:
Date Location User Value Reason
Jul-30-2020 16:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jul-30-2020 16:11:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-28-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042100
Page 196 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Histor
y Term:Interstitial Lung
Disease
Start Date: UNK/UNK/201
7
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-28-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
Interstitial Lung DiseaseInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-28-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-28-2020 11:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042101
Page 197 of 409
***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: 10031113 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 16:03:04
(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 16:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
158.0Initial Entry
3. Unit:
Date Location User Value Reason
Jul-30-2020 16:03:04
(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 16:03:04
(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 16:03:04
(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 16:03:04
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.0Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042102
Page 198 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
7.a
Date Location User Value Reason
Jul-30-2020 16:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jul-30-2020 16:03:04
(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 16:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Jul-30-2020 16:03:04
(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 16:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
FOREHEADInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042103
Page 199 of 409
***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: 10031113 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 16:03:12
(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 10:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
220530Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042104
Page 200 of 409
***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: 10031113 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 15:57:29
(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 15:57:29
(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 16:12:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 15:57:29
(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 15:57:29
(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 16:12:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWDXInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042105
Page 201 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Jul-30-2020 16:12:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWDXInitial Entry
5.b
Date Location User Value Reason
Jul-30-2020 16:12:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWDYInitial Entry
5.b Sample ID
Date Location User Value Reason
Jul-30-2020 16:12:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWDYInitial Entry
5.c
Date Location User Value Reason
Jul-30-2020 16:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWDZInitial Entry
5.c Sample ID
Date Location User Value Reason
Jul-30-2020 16:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWDZInitial Entry
5.d
Date Location User Value Reason
Jul-30-2020 16:13:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BKDYVGInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042106
Page 202 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d Sample ID
Date Location User Value Reason
Jul-30-2020 16:13:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BKDYVGInitial Entry
5.e
Date Location User Value Reason
Jul-30-2020 16:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BKDYVHInitial Entry
5.e Sample ID
Date Location User Value Reason
Jul-30-2020 16:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BKDYVHInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042107
Page 203 of 409
***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: 10031113 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 15:57:22
(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 15:57:22
(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 16:12:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jul-30-2020 15:57:22
(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 15:57:22
(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 16:12:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BGJWDBInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042108
Page 204 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Jul-30-2020 16:12:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madison
Murphy
(pfe mmurphy)Data Entry:
BGJWDBInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042109
Page 205 of 409
***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: 10031113 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 15:55:23
(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 15:55:23
(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 15:55:23
(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 15:55:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
Jul/30/2020 13:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jul-30-2020 15:55:23
(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 15:55:23
(UTC-05:00) EasternACV0PFEINFP6000 Megan
HelfData Entry:
LEFTInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042110
Page 206 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf)
7. Route:
Date Location User Value Reason
Jul-30-2020 15:55:23
(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 15:55:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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 15:55:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042111
Page 207 of 409
***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: 10031113 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 15:55:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Megan
Helf
(pfe.ahelf)Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS SU
BJECTInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042112
Page 208 of 409
***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: 10031113 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 12:26:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042113
Page 209 of 409
***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: 10031113 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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042114
Page 210 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042115
Page 211 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.e
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042116
Page 212 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042117
Page 213 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial 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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042118
Page 214 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NEW OR WORSENED JOINT P
AINInitial 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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
LEFTInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042119
Page 215 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042120
Page 216 of 409
***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: 10031113 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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-20-2020 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)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 12:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042121
Page 217 of 409
***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: 10031113 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 12:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Aug/20/2020Initial Entry
2.a
Date Location User Value Reason
Aug-20-2020 12:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 12:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-20-2020 12:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-20-2020 12:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042122
Page 218 of 409
***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: 10031113 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-20-2020 12:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
FOREHEADInitial Entry
090177e196ae3d6a\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042123
Page 219 of 409
***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: 10031113 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 12:27:48
(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 12:27:48
(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 13:25:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 12:27:48
(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 12:27:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Emily
Pierce
(pfe.epierce)Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value
…[truncated]