125742 S1 M5 CRF c4591001 1003 10031197

Document text

Page 1 of 170
***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: 10031197 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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043001
Page 2 of 170
***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: 10031197 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/13/2020
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043002
Page 3 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031197]
2.Birth Date: /1978
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:
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043003
Page 4 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020 Comments
2.Erroneous Visit Comments
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043004
Page 5 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
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: 10031197 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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043005
Page 6 of 170
***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: 10031197 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/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043006
Page 7 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043007
Page 8 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [180.0]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [24.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043008
Page 9 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [48777]
3.Randomization Group: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043009
Page 10 of 170
***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: 10031197 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/13/2020
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 [BP57CN]
5.bSample ID [BP57CP]
5.cSample ID [BP57CR]
5.dSample ID [BKDZ52]
5.eSample ID [BKDZ53]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043010
Page 11 of 170
***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: 10031197 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/13/2020
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 [BP57D6]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043011
Page 12 of 170
***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: 10031197 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/13/2020 15:21
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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043012
Page 13 of 170
***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: 10031197 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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043013
Page 14 of 170
***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: 10031197 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/3/2020
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043014
Page 15 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043015
Page 16 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043016
Page 17 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043017
Page 18 of 170
***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: 10031197 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:
Sep/3/2020
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 [BP57LM]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043018
Page 19 of 170
***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: 10031197 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: Sep/3/2020 11:43
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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043019
Page 20 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043020
Page 21 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043021
Page 22 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043022
Page 23 of 170
***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: 10031197 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:
Oct/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 [BPYL9D]
5.bSample ID [BNWKJB]
5.cSample ID [BNWKJC]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043023
Page 24 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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:
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043024
Page 25 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043025
Page 26 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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 [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043026
Page 27 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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 [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043027
Page 28 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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?
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043028
Page 29 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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:
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043029
Page 30 of 170
***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: 10031197 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:
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043030
Page 31 of 170
***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: 10031197 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 [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043031
Page 32 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043032
Page 33 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043033
Page 34 of 170
***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: 10031197 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 :Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043034
Page 35 of 170
***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: 10031197 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: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043035
Page 36 of 170
***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: 10031197 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:
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043036
Page 37 of 170
***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: 10031197 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 [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043037
Page 38 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1. DELETED ADVERSE E
VENT 1  right ureteropelvic junction obst
ruction Jan/13/2021 13
:19 NO
End Date Time:
Jan/27/2021 UNK:U
NK
 Repeating
Pages
 2. ADVERSE E
VENT 2  Congenital right ureteropelvic j
unction obstruction Dec/1/2020 U
NK:UNK NO
End Date Time:
Jan/27/2021 UNK:U
NK
 Repeating
Pages
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043038
Page 39 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[right ureteropelvic junction obstruction ]
4.Start Date Time: Jan/13/2021 13:19
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ureteropelvic junction obstruction ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043039
Page 40 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043040
Page 41 of 170
***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: 10031197 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)[Congenital right ureteropelvic junction obstruction]
4.Start Date Time: Dec/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 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?
YES
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ureteropelvic junction obstruction]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043041
Page 42 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?: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[2021124061]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043042
FDA-CBER-2021-5683-0043043
Page 44 of 170
***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: 10031197 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[ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043044
Page 45 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medication Start DateForm Instanc
e
 1.1  VACCINATIONS  NO  Quadrivalent Influenza
Vaccine Oct/UNK/2
020 Repeating
Pages
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043045
Page 46 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Quadrivalent Influenza Vaccine]
5.Date: Oct/UNK/2020
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043046
Page 47 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043047
Page 48 of 170
***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: 10031197 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?
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043048
FDA-CBER-2021-5683-0043049
Page 50 of 170
***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: 10031197 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?
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043050
FDA-CBER-2021-5683-0043051
Page 52 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043052
Page 53 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043053
Page 54 of 170
***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: 10031197 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:
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043054
Page 55 of 170
***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: 10031197 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?
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043055
Page 56 of 170
***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: 10031197 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: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043056
Page 57 of 170
***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: 10031197 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: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043057
Page 58 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043058
Page 59 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043059
Page 60 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043060
Page 61 of 170
***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: 10031197 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
Dec/17/2020
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043061
Page 62 of 170
***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: 10031197 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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043062
Page 63 of 170
***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: 10031197 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 :Dec/17/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043063
Page 64 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLCZ]
5.bSample ID [BNWKN1]
5.cSample ID [BNWKN2]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043064
Page 65 of 170
***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: 10031197 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:
Dec/17/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYLCS]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043065
Page 66 of 170
***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: 10031197 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: Dec/17/2020 14:53
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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043066
Page 67 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043067
Page 68 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043068
Page 69 of 170
***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: 10031197 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: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043069
Page 70 of 170
***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: 10031197 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/6/2021
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043070
Page 71 of 170
***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: 10031197 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/6/2021
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 [BPYLGS]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043071
Page 72 of 170
***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: 10031197 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/6/2021 14:25
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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043072
Page 73 of 170
***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: 10031197 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/5/2021
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043073
Page 74 of 170
***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: 10031197 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:
Feb/5/2021
3.Comments: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043074
Page 75 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043075
Page 76 of 170
***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: 10031197 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: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043076
Page 77 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043077
Page 78 of 170
***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: 10031197 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: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043078
Page 79 of 170
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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 :Feb/5/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043079
Page 80 of 170
***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: 10031197 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 Oct/5/2020
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043080
Page 81 of 170
***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: 10031197 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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043081
Page 82 of 170
***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: 10031197 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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043082
Page 83 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - Comments
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-13-2020 15:39:39 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
FormAug-13-2020 15:37:23 (UTC-05:00) Eastern Time
(US & Canada)Emily Pierce
(pfe.epierce)Not Applicable
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043083
Page 84 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - Comments
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
1Aug-13-2020 15:39:39 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
1Aug-13-2020 15:37:23 (UTC-05:00) Eastern Time
(US & Canada)Emily Pierce
(pfe.epierce)Not Applicable
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043084
Page 85 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - Comments
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
2Aug-13-2020 15:39:39 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)
2Aug-13-2020 15:37:23 (UTC-05:00) Eastern Time
(US & Canada)Emily Pierce
(pfe.epierce)Not Applicable
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043085
Page 86 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-13-2020 15:39:53 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)Not Applicable
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043086
Page 87 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-13-2020 15:41:54 (UTC-05:00) Eastern Time
(US & Canada)Megan Helf
(pfe.ahelf)no medical history to report
Not Applicable
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043087
Page 88 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormDec-18-2020 07:52:04 (UTC-05:00) Eastern Time
(US & Canada)Lauren Mitchell
(pfe.lschneggenburger)all inclusion met/no exclusion met
Not Applicable
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043088
Page 89 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Lauren Mitchell  N/A Dec-17-2020 14:35:59 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Oct-12-2020 10:48:03 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Megan Helf  N/A Oct-05-2020 11:33:56 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Sep-12-2020 11:21:52 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is
to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043089
Page 90 of 170
***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: 10031197 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-13-2020 14:30:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020 14:30:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043090
Page 91 of 170
***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: 10031197 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-13-2020 14:30:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/13/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043091
Page 92 of 170
***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: 10031197 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-13-2020 14:30:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10031197Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 14:30:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1978Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 14:31:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 14:31:13
(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-13-2020 14:31:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
WHITEInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043092
Page 93 of 170
***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: 10031197 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-13-2020 15:39:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Aug/13/2020Initial Entry
Aug-13-2020 15:39:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry: Initial Entry
Aug-13-2020 15:37:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Not ApplicableInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Aug-13-2020 15:39:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry: Initial Entry
Aug-13-2020 15:37:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Not ApplicableInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043093
Page 94 of 170
***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: 10031197 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-13-2020 15:40:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 15:40:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 15:40:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043094
Page 95 of 170
***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: 10031197 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-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
180.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020 15:41:16
(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
Aug-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.4Initial Entry
7.a
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043095
Page 96 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Location:: FOREHEADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020 15:41:16
(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-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020 15:41:16
(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-13-2020 15:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FOREHEADInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043096
Page 97 of 170
***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: 10031197 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-13-2020 15:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020 15:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
48777Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043097
Page 98 of 170
***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: 10031197 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-13-2020 15:40:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 15:40:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 15:44:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 15:40:26
(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-13-2020 15:40:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 15:44:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP57CNInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 15:44:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP57CNInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043098
Page 99 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b
Date Location User Value Reason
Aug-13-2020 15:44:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP57CPInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 15:44:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP57CPInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020 15:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP57CRInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 15:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP57CRInitial Entry
5.d
Date Location User Value Reason
Aug-13-2020 15:45:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BKDZ52Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 15:45:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BKDZ52Initial Entry
5.e
Date Location User Value Reason
Aug-13-2020 15:45:07
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Madison
MurphyData Entry: Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043099
Page 100 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe mmurphy) Sample ID: BKDZ53
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 15:45:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BKDZ53Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043100
Page 101 of 170
***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: 10031197 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-13-2020 15:40:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 15:40:15
(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-13-2020 15:47:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 15:40:15
(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-13-2020 15:40:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 15:47:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP57D6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 15:47:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP57D6Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043101
Page 102 of 170
***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: 10031197 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-13-2020 16:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020 16:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020 16:18:35
(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-13-2020 16:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Aug/13/2020 15:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020 16:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020 16:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043102
Page 103 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 16:18:35
(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-13-2020 16:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-13-2020 16:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
YESInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043103
Page 104 of 170
***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: 10031197 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-13-2020 15:40:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043104
Page 105 of 170
***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: 10031197 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-03-2020 13:00:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043105
Page 106 of 170
***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: 10031197 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-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043106
Page 107 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043107
Page 108 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic symptom
s present on the last day the Sub
ject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043108
Page 109 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043109
Page 110 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)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-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043110
Page 111 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4. Injection Site Body Side:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043111
Page 112 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 13:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043112
Page 113 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 13:01:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Sep/3/2020Initial Entry
2.a
Date Location User Value Reason
Sep-03-2020 13:01:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Location:: FOREHEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 13:01:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-03-2020 13:01:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-03-2020 13:01:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 13:01:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
FOREHEADInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043113
Page 114 of 170
***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: 10031197 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-03-2020 13:01:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 13:01:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 15:17:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 13:01:54
(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-03-2020 13:01:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 15:17:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BP57LMInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 15:17:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BP57LMInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043114
Page 115 of 170
***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: 10031197 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
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
Sep/3/2020 11:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043115
Page 116 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-03-2020 13:02:24
(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
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-03-2020 13:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Emily
Pierce
(pfe.epierce)Data Entry:
YESInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043116
Page 117 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 11:33:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Oct/5/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043117
Page 118 of 170
***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: 10031197 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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic symptom
s present on the last day the Sub
ject Diary was completed?:NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043118
Page 119 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.b Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043119
Page 120 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043120
Page 121 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043121
Page 122 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043122
Page 123 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
4. Injection Site Body Side:
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043123
Page 124 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 11:36:35
(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
Oct-05-2020 11:36:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043124
Page 125 of 170
***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: 10031197 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
Oct-05-2020 11:34:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 11:34:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 11:34:04
(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.
Oct-05-2020 11:34:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BPYL9DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 12:32:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BPYL9DInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043125
Page 126 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b
Date Location User Value Reason
Oct-05-2020 12:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BNWKJBInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-05-2020 12:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BNWKJBInitial Entry
5.c
Date Location User Value Reason
Oct-05-2020 12:33:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BNWKJCInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-05-2020 12:33:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BNWKJCInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043126
Page 127 of 170
***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: 10031197 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
Oct-05-2020 11:36:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-05-2020 11:36:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-05-2020 11:36:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043127
Page 128 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-09-2021 12:33:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe mcriddle)Form Deleted combine with
SAE
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe mcriddle)Form Created
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043128
Page 129 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe mcriddle)Form Created
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043129
Page 130 of 170
***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, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-05-2021 16:26:17
(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
Mar-06-2021 00:13:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed closing query on a
deleted event
Feb-09-2021 12:33:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered combine with SAE
Feb-09-2021 11:50:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical See query on
SAE of the same
name; as the period of
a SAE event when
subject was outpatient
& when it was Grade
1 can be covered by
the SAE report (which
must meet criteria at
some time); please
merge with SAE or
rename this event
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
right ureteropelvic junction obstructionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-05-2021 16:27:07 ACV0PFEINFP6000  auto query Query 1: Closed Close Auto Query
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043130
Page 131 of 170
***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, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00) Eastern Time
(US & Canada)(autoquery)
Feb-05-2021 16:27:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Jan/13/2021 13:19Transcription Error
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For right ureteropelvic
junction obstruction
Start Date 13/Feb
/2021, is a future date
relative to when it was
entered on 05/Feb
/2021. Please correct.
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Feb/13/2021 13:19Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-08-2021 11:45:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NO
End Date Time:
Jan/27/2021 UNK:UNKNew Information
Feb-05-2021 16:56:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YESNew Information
Feb-05-2021 16:27:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For right ureteropelvic
junction obstruction
End Date & Time
14/Jan/2021
UNK:UNK is before
the Start Date & Time
13/Feb/2021 13:19.
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NO
End Date Time:
Jan/14/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043131
Page 132 of 170
***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, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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
Mar-06-2021 00:13:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed closing query on a
deleted event
Feb-09-2021 12:33:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered combine with SAE
Feb-09-2021 11:51:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical COVID test
status (yes/no) during
Hosp /elective surgery
was not reported in the
SAE. Please submit a
follow-up SAE form
[#2021124061] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes,
the date and results.
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-05-2021 16:26:17
(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
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043132
Page 133 of 170
***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, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
ureteropelvic junction obstructio
nInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-05-2021 16:26:17
(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
Mar-06-2021 00:13:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed closing query on a
deleted event
Feb-09-2021 12:26:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-09-2021 12:26:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YESTranscription Error
Feb-09-2021 11:53:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Con Med is
NO; however, SAE
report states subject
received analgesia.
Please review,
harmonize reporting,
and update where
applicable
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043133
Page 134 of 170
***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, Deleted
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-08-2021
15:45:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query 1: Clo
sedAuto closed by
Validation Check:
VC_AE001_35
Feb-08-2021
11:46:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: An
sweredend date is provided
Feb-06-2021
03:35:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query 1: Op
enedDMW7171746;Response
to "What was the
outcome of this adverse
event?" is
'Recovered/Resolved' or
'Recovered/Resolved
with Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
Feb-05-2021
16:26:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
RECOVERE
D/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-05-2021 16:26:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043134
Page 135 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-05-2021 17:11:32
(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
Feb-15-2021
08:02:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 7: Closed Discrepancy has been
closed.
Feb-15-2021
07:07:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Answered Changed Information
Feb-15-2021
07:07:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Congenital right ur
eteropelvic junctio
n obstructionChanged Information
Feb-12-2021
15:20:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mina
Francisco
(pfe francm73)Query 4: Closed Response satisfies
query
Feb-11-2021
19:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 7: Opened Special Characters:
Verbatim Term
contains embedded
non-compliant
characters.
Feb-11-2021 ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Query 6: Closed Discrepancy has been
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043135
Page 136 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
17:35:29
(UTC-05:00)
Eastern Time (US
& Canada)Oracle
(pfe.PFETMS)closed.
Feb-11-2021
14:47:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Answered Transcription Error
Feb-11-2021
14:47:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Transcription Error
Feb-11-2021
14:47:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Marie Francis
(pfe mfrancis)Data Entry:
congenital right ure
teropelvic junction
obstructionTranscription Error
Feb-11-2021
14:14:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mina
Francisco
(pfe francm73)Query 4: Reissued:
OpenedDM1: congenital
right ureteropelvic
junction UPJ
obstruction should be
on one line. Please
review and update as
appropriate
Feb-11-2021
13:12:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 6: Opened Special Characters:
Verbatim Term
contains embedded
non-compliant
characters.
Feb-11-2021
11:41:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 5: Closed Discrepancy has been
closed.
Feb-11-2021
09:26:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Answered Transcription Error
Feb-11-2021
09:26:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Transcription Error
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043136
Page 137 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-11-2021
09:26:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Marie Francis
(pfe mfrancis)Data Entry:
congenital right ure
teropelvic junction
obstructionTranscription Error
Feb-10-2021
16:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 5: Opened Special Characters:
Verbatim Term
contains embedded
non-compliant
characters.
Feb-10-2021
13:43:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Pamela Benne
prod
(pfe.bennep07)Query 4: Opened DM Q: congenital
right ureteropelvic
junction UPJ
obstruction should be
on one line. Please
review and update as
appropriate
Feb-10-2021
13:42:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 3: Closed Discrepancy has been
closed.
Feb-10-2021
11:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed Information
Feb-10-2021
11:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
congenital right ure
teropelvic junction
UPJ
obstructionChanged Information
Feb-10-2021
11:23:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 3: Opened Special Characters:
Verbatim Term
contains embedded
non-compliant
characters.
Feb-10-2021
09:52:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 2: Closed Discrepancy has been
closed.
Feb-10-2021
08:30:19
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043137
Page 138 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
& Canada)
Feb-10-2021
08:30:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Marie Francis
(pfe mfrancis)Query 1: Deleted Transcription Error
Feb-10-2021
08:30:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Marie Francis
(pfe mfrancis)Data Entry:
congenital right ure
teropelvic junction
UPJ
obstructionTranscription Error
Feb-09-2021
14:53:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 2: Opened Special Characters:
Verbatim Term
contains embedded
non-compliant
characters.
Feb-09-2021
13:17:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Gladys Noi
(pfe noig)Query 1: Reissued:
Candidatepending safety update
Feb-09-2021
13:15:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
congenital right ure
teropelvic junction
(UPJ)
obstructionclarified diagnosis
and harmonized with
SAE safety report
Feb-09-2021
12:40:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered merging AE's with a
start date of 14 Dec
2020 will send new
safety report with
SAE starting on 14
Dec 2020
Feb-09-2021
10:54:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Gladys Noi
(pfe noig)Query 1: Opened SAE RECON:
Congenital right
ureteropelvic junction
(UPJ)
obstruction(onset
date:27Jan2021)was
reported in safety
database however AE
in inform is "right
ureteropelvic junction
obstruction"(onset
date:26Jan2021).
Please confirm and
update CRF or Safety
DB.
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043138
Page 139 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-05-2021
17:11:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
right ureteropelvic j
unction obstructionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-09-2021 12:42:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Dec/1/2020 UNK:UNKNew Information
Feb-09-2021 12:36:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-09-2021 12:36:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Dec/14/2020 UNK:UNKTranscription Error
Feb-09-2021 12:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For right ureteropelvic
junction obstruction
Start Date 14/Dec
/2021, is a future date
relative to when it was
entered on 09/Feb
/2021. Please correct.
Feb-09-2021 12:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Dec/14/2021 UNK:UNKChanged Information
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Jan/26/2021 16:13Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-23-2021 14:33:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-09-2021 12:46:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered combine AE's with a
start date of 01 Dec
2020 will update
safety SAE #
2021124061 to reflect
more accurate start
date
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043139
Page 140 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-09-2021 12:36:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-09-2021 12:35:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For right ureteropelvic
junction obstruction
End Date & Time
27/Jan/2021
UNK:UNK is before
the Start Date & Time
14/Dec/2021
UNK:UNK.
Feb-09-2021 11:47:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical start date is
27Jan21; however
SAE report states
'several wks flank pain
prior to 20Dec20'. In
Vaccine study, SAE
start date is day event
starts; not day it meets
serious criteria (item
11 in vaccine SAE
instruct); please review
start date.
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NO
End Date Time:
Jan/27/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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
Feb-23-2021 14:32:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043140
Page 141 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-11-2021 15:02:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered SAE updated with
COVID testing
Feb-10-2021 15:47:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical COVID test
status (yes/no) during
Hosp/surgery was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2021124061] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes,
the date and results.
Feb-10-2021 13:42:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043141
Page 142 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
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
Feb-10-2021 11:25:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE congenital
right ureteropelvic
junction UPJ
obstruction: Response
to "Is the adverse
event serious?" is 'Yes'
but "Serious Adverse
Event Number" is
blank.
Feb-10-2021 08:30:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE congenital
right ureteropelvic
junction UPJ
obstruction : Response
to "Is the adverse
event serious?" is 'Yes'
but "Serious Adverse
Event Number" is
blank.
Feb-09-2021 13:15:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE congenital
right ureteropelvic
junction (UPJ)
obstruction : Response
to "Is the adverse
event serious?" is 'Yes'
but "Serious Adverse
Event Number" is
blank.
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE right
ureteropelvic junction
obstruction : Response
to "Is the adverse
event serious?" is 'Yes'
but "Serious Adverse
Event Number" is
blank.
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YES
Is this serious event associated withInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043142
Page 143 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
congenital anomaly or birth defect?
YES
Did this serious event result in death
?
NO
Did this serious event require or prol
ong hospitalization?
YES
Did this serious event result in persis
tent or significant disability/incapacit
y?
NO
Is this serious event life threatening?
NO
Other medically important serious ev
ent
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.
Date Location User Value Reason
Feb-05-2021 17:11:32
(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
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
ureteropelvic junction obstructioInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043143
Page 144 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
n
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-05-2021 17:11:32
(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
Feb-23-2021 14:33:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-11-2021 10:41:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Feb-11-2021 10:41:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
YESChanged Information
Feb-10-2021 15:45:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Con Med is
NO; however, SAE
report states subject
received analgesia.
Please review,
harmonize reporting,
and update where
applicable
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-05-2021 17:11:32
(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
Feb-05-2021 17:11:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043144
Page 145 of 170
***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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-05-2021 17:11:32
(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
Feb-10-2021 13:42:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Pamela Benne
prod
(pfe.bennep07)Data Entry:
2021124061Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043145
Page 146 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Dec-18-2020 10:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Lauren Mitchell
(pfe.lschneggenburger)Form Created
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043146
Page 147 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
eCRF Audit Trail History
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Dec-18-2020 10:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Dec-18-2020 10:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Dec-18-2020 10:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter the full
trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Dec-18-2020 10:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Quadrivalent Influenza VaccineInitial Entry
5. Date:
Date Location User Value Reason
Dec-18-2020 10:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Oct/UNK/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043147
Page 148 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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
Dec-17-2020 14:35:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Dec/16/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043148
Page 149 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-18-2020 07:44:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 1: Closed Close Auto Query
Dec-18-2020 05:31:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe nairr29)Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Dec-17-2020 14:36:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Dec-17-2020 14:36:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed t
o have received only placebo a
t Vaccination 1/2Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043149
Page 150 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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
Dec-17-2020 14:36:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Dec/17/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043150
Page 151 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
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: 10031197 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
Dec-17-2020 14:36:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/17/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043151
Page 152 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
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: 10031197 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
Dec-18-2020 07:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Dec/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-18-2020 07:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020 07:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043152
Page 153 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
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: 10031197 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
Dec-18-2020 07:52:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 07:52:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 12:13:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 1: Deleted Close Auto Query
Dec-18-2020 07:52:42
(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.
Dec-18-2020 07:52:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 12:13:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BPYLCZInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 12:13:54
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Madison
MurphyData Entry:
BPYLCZInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043153
Page 154 of 170
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe mmurphy)
5.b
Date Location User Value Reason
Dec-18-2020 12:14:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BNWKN1Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 12:14:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BNWKN1Initial Entry
5.c
Date Location User Value Reason
Dec-18-2020 12:14:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BNWKN2Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 12:14:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BNWKN2Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043154
Page 155 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
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: 10031197 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
Dec-18-2020 07:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 07:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 12:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 1: Deleted Close Auto Query
Dec-18-2020 07:52:54
(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.
Dec-18-2020 07:52:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 12:13:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BPYLCSInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 12:13:32
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Madison
MurphyData Entry:
BPYLCSInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043155
Page 156 of 170
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) (pfe mmurphy)
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043156
Page 157 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 10031197 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
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Dec/17/2020 14:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043157
Page 158 of 170
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-18-2020 07:53:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
YESInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043158
Page 159 of 170
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-18-2020 07:44:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
Dec/16/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-18-2020 07:44:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Lauren Mitchell
(pfe.lschneggenburger)Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043159
Page 160 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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
Jan-06-2021 15:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Jan/6/2021Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043160
Page 161 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
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: 10031197 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
Jan-06-2021 13:50:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-06-2021 13:50:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021 13:50:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-06-2021 13:50:21
(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.
Jan-06-2021 13:50:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
YES
Date of Collection:
Jan/6/2021Initial Entry
5.a
Date Location User Value Reason
Jan-06-2021 13:50:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
Sample ID: BPYLGSInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-06-2021 13:50:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe mmurphy)Data Entry:
BPYLGSInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043161
Page 162 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 10031197 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
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Jan/6/2021 14:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043162
Page 163 of 170
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-06-2021 16:05:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043163
Page 164 of 170
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-09-2021
15:55:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by Validation Check:
VC_SV001_11
Feb-09-2021
08:33:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Query
1: Ans
weredChanged data per query
Feb-09-2021
08:19:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7195178;V103 Visit Date is
entered, but Disposition -
Treatment form at
FURTHER_VACCINATION_EOT
visit is not completed. Please
review and update as appropriate.
Feb-08-2021
13:54:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data
Entry
:
Feb/5/
2021Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043164
Page 165 of 170
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-08-2021 13:55:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-08-2021 13:55:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Contact:
Feb/5/2021Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043165
Page 166 of 170
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 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
Feb-10-2021
01:23:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Adarsh Prabhu
(pfe.prabha11)Query 3: Close
dIncorrect query
Feb-09-2021
16:36:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query 3: Open
edDMW7210903;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-09-2021
08:33:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
Feb/5/2021Initial Entry
Jan-18-2021
20:03:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hui Pan
(pfe.panh18)Query 1: Close
dResponse satisfies
query
Jan-15-2021
16:00:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query 2: Close
dAuto closed by
Validation Check:
VC_DS001_21
Jan-15-2021
12:09:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Ans
weredTranscription Error
Jan-15-2021
12:09:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription Error
Jan-15-2021
12:09:59ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry: Transcription Error
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043166
Page 167 of 170
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00)
Eastern Time
(US & Canada)
Jan-14-2021
21:18:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query 2: Open
edDMW6841946;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Jan-10-2021
19:51:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hui Pan
(pfe.panh18)Query 1: Open
edClinQuery: The
treatment period is
defined as vax3 visit
through the 1-month
post vaccination visit
after vax4. EOT date
should therefore
match date of visit at
visit 103. Please
review.
Jan-06-2021
16:06:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Jan/6/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-09-2021 08:33:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
Jan-15-2021 12:09:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Jan-06-2021 16:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-09-2021 08:33:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043167
Page 168 of 170
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital
Subject No: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-28-2021 13:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response satisfies
query
Jan-28-2021 10:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-28-2021 10:21:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry: Transcription Error
Jan-28-2021 01:30:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Amol Shinde
(pfe.shinda18)Query 1: Opened DM: As subject is in
follow up phase
kindly consider
removing data from
this field. Thank you.
Jan-06-2021 16:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043168
Page 169 of 170
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-05-2020 11:36:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-13-2020 15:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-13-2020 15:40:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-05-2020 11:36:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Aug-13-2020 15:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
Aug-13-2020 15:40:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043169
Page 170 of 170
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail 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: 10031197 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-12-2020 11:21:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Edward
Walsh
(pfe.ewalsh)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d6b\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043170