125742 S1 M5 CRF c4591001 1003 10031149

Document text

Page 1 of 213
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042315
Page 2 of 213
***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: 10031149 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
Aug/5/2020
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042316
Page 3 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031149]
2.Birth Date: /1950
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:
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0042317
Page 4 of 213
***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: 10031149 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/5/2020
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042318
Page 5 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042319
Page 6 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042320
Page 7 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042321
Page 8 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042322
Page 9 of 213
***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: 10031149 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/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0042323
Page 10 of 213
***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: 10031149 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:[right eye cataract]
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/2019
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right eye cataract removal]
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[high blood pressure]
Start Date: UNK/UNK/2009
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastrointestinal reflux disorder]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042324
Page 11 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[benign prostatic hypertrophy]
Start Date: UNK/UNK/2017
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[environmental allergies - hives]
Start Date: UNK/UNK/2019
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: UNK/UNK/1959
Ongoing: NO
End Date:
UNK/UNK/1959
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: UNK/UNK/1959
Ongoing: NO
End Date:
UNK/UNK/1959
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042325
Page 12 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II diabetes]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042326
Page 13 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [191.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [26.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042327
Page 14 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [222359]
3.Randomization Group: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042328
Page 15 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/5/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP571D]
5.bSample ID [BP571F]
5.cSample ID [BP571G]
5.dSample ID [BKDYZB]
5.eSample ID [BKDYZC]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042329
Page 16 of 213
***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: 10031149 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/5/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP571R]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042330
Page 17 of 213
***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: 10031149 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/5/2020 15:19
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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042331
Page 18 of 213
***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: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042332
Page 19 of 213
***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: 10031149 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/26/2020
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042333
Page 20 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042334
Page 21 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042335
Page 22 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042336
Page 23 of 213
***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: 10031149 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/26/2020
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 [BP57K3]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042337
Page 24 of 213
***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: 10031149 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/26/2020 14:57
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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042338
Page 25 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042339
Page 26 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042340
Page 27 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042341
Page 28 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYL78]
5.bSample ID [BNWKD3]
5.cSample ID [BNWKD4]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042342
Page 29 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042343
Page 30 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042344
Page 31 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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 [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042345
Page 32 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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 [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042346
Page 33 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042347
Page 34 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042348
Page 35 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042349
Page 36 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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 [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042350
Page 37 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042351
Page 38 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042352
Page 39 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042353
Page 40 of 213
***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: 10031149 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: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042354
Page 41 of 213
***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: 10031149 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:
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042355
Page 42 of 213
***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: 10031149 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 [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042356
Page 43 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  small bowel obstr
uction Aug/8/2020 00:17  NO
End Date Time:
Aug/10/2020 00:13
 Repeating
Pages
 2.ADVERSE EV
ENT 2  suspected panic att
ack Dec/28/2020 UNK:
UNK NO
End Date Time:
Dec/29/2020 UNK:UNK
 Repeating
Pages
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042357
Page 44 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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)[small bowel obstruction]
4.Start Date Time: Aug/8/2020 00:17
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/10/2020 00:13
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?
YES
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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042358
Page 45 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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:
[SAE - unplanned bowel obstruction]
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?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020315748]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042359
Page 46 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[suspected panic attack]
4.Start Date Time: Dec/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/29/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042360
Page 47 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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:
[suspected panic attack]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021001133]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042361
Page 48 of 213
***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: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042362
Page 49 of 213
***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: 10031149 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[ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042363
Page 50 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042364
Page 51 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042365
Page 52 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042366
Page 53 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042367
FDA-CBER-2021-5683-0042368
Page 55 of 213
***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: 10031149 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?
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042369
FDA-CBER-2021-5683-0042370
Page 57 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042371
Page 58 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042372
Page 59 of 213
***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: 10031149 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:
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042373
Page 60 of 213
***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: 10031149 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?
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042374
Page 61 of 213
***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: 10031149 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: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042375
Page 62 of 213
***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: 10031149 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: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042376
Page 63 of 213
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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/14/2021
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042377
Page 64 of 213
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042378
Page 65 of 213
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042379
Page 66 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042380
Page 67 of 213
***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: 10031149 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: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042381
Page 68 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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/15/2021
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042382
Page 69 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/15/2021
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042383
Page 70 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042384
Page 71 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/15/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042385
Page 72 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
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 [BPYLJT]
5.bSample ID [BNWKVD]
5.cSample ID [BNWKVF]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042386
Page 73 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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/15/2021
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 [BPYLJR]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042387
Page 74 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/15/2021 09:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042388
Page 75 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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/3/2021
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042389
Page 76 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/3/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLMB]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042390
Page 77 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/3/2021 10:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042391
Page 78 of 213
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042392
Page 79 of 213
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/3/2021
3.Comments: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042393
Page 80 of 213
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042394
Page 81 of 213
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042395
Page 82 of 213
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042396
Page 83 of 213
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042397
Page 84 of 213
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
:Mar/3/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042398
Page 85 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/23/2020
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042399
Page 86 of 213
***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: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042400
Page 87 of 213
***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: 10031149 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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042401
Page 88 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-20-2021 14:50:00 (UTC-05:00) Eastern
Time (US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042402
Page 89 of 213
***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: 10031149 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
Madison
Murphy N/A Feb-03-2021 12:21:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Jan-21-2021 22:07:57 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Lauren
Mitchell N/A Dec-22-2020 10:04:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Sep-30-2020 16:40:35 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042403
Page 90 of 213
***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: 10031149 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 Sep-23-2020 14:11:00 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Sep-11-2020 12:55:23 (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.
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042404
Page 91 of 213
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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
Aug-05-2020 14:54:17
(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
Aug-05-2020 14:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042405
Page 92 of 213
***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: 10031149 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
Aug-05-2020 14:54:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/5/2020Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042406
Page 93 of 213
***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: 10031149 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
Aug-05-2020 14:54:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10031149Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-05-2020 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1950Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-05-2020 14:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-05-2020 14:54:36
(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
Aug-05-2020 14:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
WHITEInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
(b) (6)
FDA-CBER-2021-5683-0042407
Page 94 of 213
***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: 10031149 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-05-2020 14:54:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/5/2020Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042408
Page 95 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participa
nts between the ages of
18 and 55 years, inclusiv
e, 65 and 85 years, inclu
sive, or 18 and 85 years,
inclusive, at randomizati
on (dependent upon stud
y stage)
Criter
ion m
et?:YES
Criter
ion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) EasternACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Male or female participants betwInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042409
Page 96 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) een the ages of 18 and 55 years, i
nclusive, 65 and 85 years, inclusi
ve, or 18 and 85 years, inclusive,
at randomization (dependent upo
n study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Inclus
ion Nu
mber:2
Criter
ion De
scripti
on:Participants who are wil
ling and able to comply
with all scheduled visits
, vaccination plan, labor
atory tests, lifestyle con
siderations, and other st
udy procedures
Criter
ion me
t?:YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042410
Page 97 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Participants who are willing and
able to comply with all schedule
d visits, vaccination plan, laborat
ory tests, lifestyle considerations,
and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042411
Page 98 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Inclus
ion N
umber
:3
Criter
ion De
scripti
on:Healthy participants wh
o are determined by me
dical history, physical e
xamination, and clinical
judgment of the investig
ator to be eligible for in
clusion in the study
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042412
Page 99 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Inclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Healthy participants who are det
ermined by medical history, phys
ical examination, and clinical jud
gment of the investigator to be el
igible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042413
Page 100 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criter
ion De
scripti
on:Capable of giving perso
nal signed informed con
sent, which includes co
mpliance with the requir
ements and restrictions l
isted in the ICD and in t
his protocol
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042414
Page 101 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Inclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Capable of giving personal signe
d informed consent, which inclu
des compliance with the require
ments and restrictions listed in th
e ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042415
Page 102 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criter
ion De
scripti
on:Other medical or psychi
atric condition incl. rece
nt (within past year) or a
ctive suicidal ideation/b
ehavior/lab abnormality
that may increase the ris
k of study participation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Other medical or psychiatric con
dition incl. recent (within past ye
ar) or active suicidal ideation/be
havior/lab abnormality that may
increase the risk of study particip
ationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042416
Page 103 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descr
iption:Known infection with
human immunodeficie
ncy virus (HIV), hepat
itis C virus (HCV), or
hepatitis B virus (HB
V)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042417
Page 104 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Known infection with human im
munodeficiency virus (HIV), hep
atitis C virus (HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042418
Page 105 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criter
ion De
scripti
on:History of severe advers
e reaction associated wit
h a vaccine and/or sever
e allergic reaction (eg, a
naphylaxis) to any com
ponent of the study inter
vention(s)
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042419
Page 106 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
History of severe adverse reactio
n associated with a vaccine and/o
r severe allergic reaction (eg, ana
phylaxis) to any component of th
e study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medica
tions intended to p
revent COVID-19Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042420
Page 107 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Receipt of medications intended
to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclus
ion Nu8Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042421
Page 108 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
mber:
Criteri
on Des
criptio
n:Immunocompromised i
ndividuals with known
or suspected immunode
ficiency, as determined
by history and/or labora
tory/physical examinati
on
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX08A00
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042422
Page 109 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Immunocompromised individual
s with known or suspected immu
nodeficiency, as determined by h
istory and/or laboratory/physical
examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042423
Page 110 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Bleeding diathesis or co
ndition associated with
prolonged bleeding that
would, in the opinion of
the investigator, contrai
ndicate intramuscular in
jection
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042424
Page 111 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Bleeding diathesis or condition a
ssociated with prolonged bleedin
g that would, in the opinion of th
e investigator, contraindicate intr
amuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeedingInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042425
Page 112 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Women who are pregnant or brea
stfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclusion N
umber:12Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042426
Page 113 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccine
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Previous vaccination with any co
ronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042427
Page 114 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemic
corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX13A01Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042428
Page 115 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.i Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Subjects who receive immunosu
ppressive therapy, such as cytoto
xic agents or systemic corticoster
oidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042429
Page 116 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criteri
on Des
criptio
n:Receipt of blood/plasm
a products or immunogl
obulin, from 60 days be
fore study intervention
administration or plann
ed receipt throughout th
e study
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042430
Page 117 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.j Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Receipt of blood/plasma product
s or immunoglobulin, from 60 da
ys before study intervention adm
inistration or planned receipt thr
oughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
EX14A01Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042431
Page 118 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
2.k
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other s
tudies involving study
intervention within 28
days prior to study entr
y and/or during study
participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX15A01Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042432
Page 119 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.k Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Participation in other studies inv
olving study intervention within
28 days prior to study entry and/
or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042433
Page 120 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Previous participation in other st
udies involving study interventio
n containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
EX16A01Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042434
Page 121 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.m
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees directl
y involved in the condu
ct of the study, site staff
otherwise supervised by
the investigator, and thei
r respective family mem
bers
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042435
Page 122 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.m Exclusion Number:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in th
e conduct of the study, site staff
otherwise supervised by the inve
stigator, and their respective fam
ily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-05-2020 14:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
EX21A01Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042436
Page 123 of 213
***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: 10031149 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
Aug-05-2020 14:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-05-2020 14:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-05-2020 14:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042437
Page 124 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-05-2020 14:57:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:right eye catar
act
Start Date: Feb/UNK/201
9
Ongoing: NO
End Date:
Feb/UNK/2
019Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-05-2020 14:57:02
(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
Aug-05-2020 14:57:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
right eye cataractInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-05-2020 14:57:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Feb/UNK/2019Initial Entry
1.a Ongoing:
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042438
Page 125 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-05-2020 14:57:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NO
End Date:
Feb/UNK/2019Initial Entry
1.b
Date Location User Value Reason
Aug-05-2020 14:57:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:right eye cataract
removal
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
Feb/UNK/201
9Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042439
Page 126 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-05-2020 14:57:47
(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
Aug-05-2020 14:57:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
right eye cataract removalInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-05-2020 14:57:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Feb/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-05-2020 14:57:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NO
End Date:
Feb/UNK/2019Initial Entry
1.c
Date Location User Value Reason
Aug-05-2020 14:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:high blood pre
ssure
Start Date: UNK/UNK/20
09
Ongoing: YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042440
Page 127 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Aug-05-2020 14:58:39
(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
Aug-05-2020 14:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
high blood pressureInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-05-2020 14:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2009Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-05-2020 14:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-05-2020 15:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:gastrointestinal ref
lux disorder
Start Date: UNK/UNK/2013
Ongoing: YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042441
Page 128 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Aug-05-2020 15:00:30
(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
Aug-05-2020 15:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
gastrointestinal reflux disorderInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-05-2020 15:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2013Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-05-2020 15:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-05-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histo
ry Term:benign prostatic h
ypertrophy
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042442
Page 129 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Line/MH Number:
Date Location User Value Reason
Aug-05-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-05-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
benign prostatic hypertrophyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-05-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-05-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-05-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:environmental alle
rgies - hives
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042443
Page 130 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Line/MH Number:
Date Location User Value Reason
Aug-05-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-05-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
environmental allergies - hivesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-05-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-05-2020 15:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-18-2020 11:38:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:appendicitis
Start Date: UNK/UNK/195
9Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042444
Page 131 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/
1959
1.g Line/MH Number:
Date Location User Value Reason
Aug-18-2020 11:38:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 11:38:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
appendicitisInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-18-2020 11:38:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/1959Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-18-2020 11:38:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NO
End Date:
UNK/UNK/1959Initial Entry
1.h
Date Location User Value Reason
Aug-18-2020 11:39:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb 8Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042445
Page 132 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
er:
Medical History
Term:appendectomy
Start Date: UNK/UNK/195
9
Ongoing: NO
End Date:
UNK/UNK/
1959
1.h Line/MH Number:
Date Location User Value Reason
Aug-18-2020 11:39:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 11:39:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
appendectomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-18-2020 11:39:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/1959Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-18-2020 11:39:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NO
End Date:
UNK/UNK/1959Initial Entry
1.i
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042446
Page 133 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Dec-22-2020 10:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:Type II diabet
es
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Dec-22-2020 10:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-22-2020 10:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Type II diabetesInitial Entry
1.i Start Date:
Date Location User Value Reason
Dec-22-2020 10:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Dec-22-2020 10:04:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042447
Page 134 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10031149 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-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
191.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-05-2020 15:22:43
(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
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042448
Page 135 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.6Initial Entry
7.a
Date Location User Value Reason
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-05-2020 15:22:43
(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
Aug-05-2020 15:22:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FOREHEADInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042449
Page 136 of 213
***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: 10031149 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
Aug-05-2020 15:23:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-05-2020 15:23:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
222359Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042450
Page 137 of 213
***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: 10031149 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-05-2020 14:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 14:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 15:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 14:58:00
(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-05-2020 14:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020 15:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP571DInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042451
Page 138 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 15:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP571DInitial Entry
5.b
Date Location User Value Reason
Aug-05-2020 15:49:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP571FInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-05-2020 15:49:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP571FInitial Entry
5.c
Date Location User Value Reason
Aug-05-2020 15:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP571GInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-05-2020 15:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP571GInitial Entry
5.d
Date Location User Value Reason
Aug-05-2020 15:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BKDYZBInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042452
Page 139 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d Sample ID
Date Location User Value Reason
Aug-05-2020 15:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BKDYZBInitial Entry
5.e
Date Location User Value Reason
Aug-05-2020 15:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BKDYZCInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-05-2020 15:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BKDYZCInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042453
Page 140 of 213
***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: 10031149 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-05-2020 14:58:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-05-2020 14:58:08
(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-05-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-05-2020 14:58:08
(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-05-2020 14:58:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-05-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP571RInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042454
Page 141 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Aug-05-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP571RInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042455
Page 142 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/5/2020 15:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042456
Page 143 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-05-2020 15:56:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042457
Page 144 of 213
***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: 10031149 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
Aug-05-2020 15:21:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042458
Page 145 of 213
***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: 10031149 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-26-2020 14:31:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/26/2020Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042459
Page 146 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) EasternACV0PFEINFP6000  Megan
HelfData Entry:
Symptom:: FAInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042460
Page 147 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf) TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042461
Page 148 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042462
Page 149 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042463
Page 150 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042464
Page 151 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED MUSCLE
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-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042465
Page 152 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
3. Injection Site Location:
Date Location User Value Reason
Aug-26-2020 14:32:11
(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-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042466
Page 153 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042467
Page 154 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 14:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042468
Page 155 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 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-26-2020 15:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/26/2020Initial Entry
2.a
Date Location User Value Reason
Aug-26-2020 15:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 15:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-26-2020 15:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-26-2020 15:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042469
Page 156 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 15:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FOREHEADInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042470
Page 157 of 213
***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: 10031149 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-26-2020 14:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 14:31:07
(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-26-2020 15:10:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 14:31:07
(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-26-2020 14:31:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 15:10:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP57K3Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042471
Page 158 of 213
***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: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 15:10:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP57K3Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042472
Page 159 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/26/2020 14:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042473
Page 160 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-26-2020 15:27:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042474
Page 161 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 14:11:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Sep/23/2020Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042475
Page 162 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) EasternACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: FAInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042476
Page 163 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042477
Page 164 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042478
Page 165 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042479
Page 166 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042480
Page 167 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042481
Page 168 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-23-2020 14:11:46
(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
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042482
Page 169 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042483
Page 170 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 14:11:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042484
Page 171 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 14:11:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 14:11:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 16:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 14:11:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-23-2020 14:11:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 16:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID: BPYL78Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042485
Page 172 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 16:00:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
BPYL78Initial Entry
5.b
Date Location User Value Reason
Sep-23-2020 16:00:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID: BNWKD3Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 16:00:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
BNWKD3Initial Entry
5.c
Date Location User Value Reason
Sep-23-2020 16:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID: BNWKD4Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 16:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
BNWKD4Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042486
Page 173 of 213
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-23-2020 14:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 14:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 14:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042487
Page 174 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Form Created
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042488
Page 175 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Dec-31-2020 12:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Form Created
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042489
Page 176 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Aug-19-2020 08:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Eugene Lam
(pfe.lame03)Query 1: Closed Response satisfies
query
Aug-18-2020 11:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered history of
appendectomy
updated in medical
history
Aug-17-2020 13:12:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Eugene Lam
(pfe.lame03)Query 1: Opened Please review if the
participant had a
history of
abdominal surgery
and update in the
medical history
page (along with the
underlying
condition causing
the surgery) if
appropriate. Thank
you.
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
small bowel obstructionInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042490
Page 177 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4. Start Date Time:
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/8/2020 00:17Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-13-2020 13:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NO
End Date Time:
Aug/10/2020 00:13New Information
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NO
End Date Time:
Aug/10/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-14-2020 17:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed
Hassan
(pfe.hassaa38)Query 1: Closed Response satisfies
query
Aug-14-2020 15:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Query 1: Answered hospitalization was
required
Aug-14-2020 15:24:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed
Hassan
(pfe.hassaa38)Query 1: Reissued:Opened Please can you
confirm what
intervention was
required? As it
appears the question
to 'did the subject
require
hospitalisation' is
no. Else clarify.
Thanks
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042491
Page 178 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-14-2020 14:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Query 1: Answered urgent intervention
was required
Aug-14-2020 13:15:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed
Hassan
(pfe.hassaa38)Query 1: Opened Please can you
review the toxicity
of this AE as grade
4 currently refers to:
life threatening
consequences,
requiring
intervention
indicated (eCRF
8.45.5) Thanks
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 00:37:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Closed Query closed; will
follow for SAE
update with
requested COVID
test info
Oct-27-2020 15:26:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 4: Answered follow up SAE
regarding COVID
test has been
updated and faxed
Oct-25-2020 21:23:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Opened COVID testing has
not been reported in
the SAE submitted
to safety. Please
submit a follow-up
SAE form
[#2020315748] to
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042492
Page 179 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Aug-18-2020 09:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gary Steven
Friedman
(pfe friedg01)Query 2: Closed duplicate query
already answered.
Query closed.
GFriedman
18Aug2020 0946hr
UTC -4
Aug-17-2020 14:46:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jeffrey
Signora
(pfe.signoj01)Query 1: Closed Pfizer field only
Aug-17-2020 01:15:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 3: Deleted same query already
present
Aug-14-2020 15:35:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate For AE small bowel
obstruction:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-14-2020 15:35:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YESTranscription Error
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042493
Page 180 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
YES
Other medically important ser
ious event
NO
Aug-14-2020 15:21:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered scan shows dilated
loops small bowel,
possibly infectious
or ileus. no clear cut
off seen, but could
be obstruction.
Aug-14-2020 14:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered still have not
received SAE Event
number from Pfizer
Aug-14-2020 12:59:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gary Steven
Friedman
(pfe friedg01)Query 2: Opened Was there or was
there not
radiographic
evidence of SBO
(CT or Abd XR)? If
not, then your
clinical judgment be
that ileus or
abdominal
distension or
alternative term is
more consistent with
the clinical course?
Aug-14-2020 11:43:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Opened For AE small bowel
obstruction:
Response to "Is the
adverse event
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042494
Page 181 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE small bowel
obstruction:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
YES
Other medically important ser
ious eventInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042495
Page 182 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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.
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Aug-20-2020 08:52:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
SAE - unplanned bowel o
bstructionChanged
Information
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Aug-13-2020 13:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042496
Page 183 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-13-2020 13:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-13-2020 11:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Aug-17-2020 15:51:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gladys
Noi
(pfe noig)Data Entry:
2020315748Initial Entry
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042497
Page 184 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Dec-31-2020 12:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-31-2020 12:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-25-2021 21:52:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Jan-25-2021 21:52:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Jan-22-2021 23:12:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Jan-22-2021 09:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 3: Answered subject does not
have any relevant
medical history
pertaining to the
SAE. Safety report
was updated on 21
Jan 2021
Jan-22-2021 09:51:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered we have no
additional
Cardiology
assessments.
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042498
Page 185 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Safety report
updated on 21Jan
2021
Jan-22-2021 09:50:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered D dimer and HGB
results and
parameters have
been updated in
safety report and
sent on 21 Jan
2021
Jan-08-2021 09:36:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Opened CLINICAL Please
submit relevant
Med History to
SAE report,
including all
conditions for
which subject is
receiving
medication
Jan-08-2021 09:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical SAE
report documents
bradycardia (HR
56), RBBB and
subject reported
rapid heart
rate/possible
tachycardia (HR
90 documented);
please submit any
additional
cardiology
assessment to the
SAE in a safety
update.
Jan-08-2021 09:28:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL
Significant
abnormal lab
results in SAE
report require
additional info;
please submit D
dimer normal
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042499
Page 186 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
range/test date,
and Hgb normal
range
Dec-31-2020 12:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
suspected panic attackInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-31-2020 12:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Dec/28/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-31-2020 12:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NO
End Date Time:
Dec/29/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-31-2020 12:27:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-20-2021
23:04:02
(UTC-05:00) EasternACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
090177e196ae3d66\Final\Final On: 01-Apr-2021 04:33 (GMT)
FDA-CBER-2021-5683-0042500
Page 187 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031149 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
Jan-20-2021
16:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 3: Answered New Information
Jan-20-2021
16:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YES
Is this serious event ass
ociated with congenital
anomaly or birth defect
?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
NO
Did this serious event r
esult in persistent or si
gnificant disability/inc
apacity?
NO
Is this serious event lif
e threatening?
NO
Other medically import
ant serious event
YESNew Information
Jan-08-2021
09:26:37ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 3: Opened Clinical E
…[truncated]