Document text
Page 1 of 143
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827924
Page 2 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/16/2020
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827925
Page 3 of 143
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Demography
1.Subject ID [12231182]
2.Birth Date: /1936
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:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827926
Page 4 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827927
Page 5 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827928
Page 6 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827929
Page 7 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dislocated shoulder]
Start Date: UNK/UNK/1966
Ongoing: NO
End Date:
UNK/UNK/1967
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[atrial fibrillation]
Start Date: UNK/UNK/1998
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diverticulitis]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827930
Page 8 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2001
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastroesophageal reflux]
Start Date: UNK/UNK/2001
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[barrett's Esophagitus]
Start Date: UNK/UNK/2017
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign Prostatic Hypertrophy]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827931
Page 9 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
2.Weight: [78.4]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [27.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827932
Page 10 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/16/2020
2.Randomization Number: [260407]
3.Randomization Group: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827933
Page 11 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPXXMJ]
5.bSample ID [BPXXMK]
5.cSample ID [BPXXML]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827934
Page 12 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPXXMH]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827935
Page 13 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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/16/2020 13:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827936
Page 14 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827937
Page 15 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827938
Page 16 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827939
Page 17 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
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 [BPW1NZ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827940
Page 18 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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: Oct/9/2020 11:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827941
Page 19 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827942
Page 20 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BPW1RD]
5.bSample ID [BPW1RF]
5.cSample ID [BPW1RG]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827943
Page 21 of 143
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827944
Page 22 of 143
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827945
Page 23 of 143
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827946
Page 24 of 143
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827947
Page 25 of 143
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827948
Page 26 of 143
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827949
Page 27 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827950
Page 28 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827951
Page 29 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827952
Page 30 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827953
Page 31 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827954
Page 32 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827955
Page 33 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827956
Page 34 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827957
Page 35 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827958
Page 36 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827959
Page 37 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827960
Page 38 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Unplanned Assessments
1.Assessments
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827961
Page 39 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827962
Page 40 of 143
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827963
Page 41 of 143
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827964
Page 42 of 143
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827965
Page 43 of 143
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827966
Page 44 of 143
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827967
Page 45 of 143
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827968
Page 46 of 143
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827969
Page 47 of 143
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827970
Page 48 of 143
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827971
Page 49 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827972
Page 50 of 143
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827973
Page 51 of 143
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827974
Page 52 of 143
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 progression of dive
rticulitis Sep/29/2020
13:00 YES Repeating
Pages
2.ADVERSE E
VENT 2 Pericolonic Absces
s Oct/13/2020
19:00 YES Repeating
Pages
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827975
Page 53 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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)[progression of diverticulitis]
4.Start Date Time: Sep/29/2020 13:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827976
Page 54 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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:
[History of diverticulitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020393225]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827977
Page 55 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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)[Pericolonic Abscess]
4.Start Date Time: Oct/13/2020 19:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827978
Page 56 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[related to an underlying condition reported in Medical History]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020399225]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827979
Page 57 of 143
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Categ
oryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827980
Page 58 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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[ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827981
Page 59 of 143
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827982
Page 60 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).[ ]
5.Date: //
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827983
Page 61 of 143
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827984
Page 62 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827985
Page 63 of 143
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827986
Page 64 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827987
Page 65 of 143
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827988
Page 66 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827989
Page 67 of 143
***Confidential***
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827990
Page 68 of 143
***Confidential***
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Booster Dose Trigger Form
1.Select appropriate response -
Will the participant return for
consent/eligibility assessment
for the booster dose visit?
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827991
Page 69 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/22/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827992
Page 70 of 143
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827993
Page 71 of 143
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827994
Page 72 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/6/2020
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827995
Page 73 of 143
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827996
Page 74 of 143
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jessica Tuan Approved Mar-19-2021 21:15:40 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, 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.
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827997
Page 75 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormSep-16-2020 18:07:19 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827998
Page 76 of 143
***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, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jessica Tuan Approved Mar-19-2021 21:15:40 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, 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.
N/A Feb-02-2021 12:15:09 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica Tuan Approved Nov-11-2020 15:16:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, 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.
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827999
Page 77 of 143
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-16-2020
18:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-16-2020
18:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828000
Page 78 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020
18:06:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Ob
tained
Sep/16/2020Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828001
Page 79 of 143
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-29-2020
00:11:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed event added in ae crf
Oct-28-2020
09:13:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dChanged data per query
Oct-15-2020
06:30:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020399225
Pericolonic abscess(onset
date:13OCT2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-16-2020
18:06:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12231182Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020 18:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1936Enrollment Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0828002
Page 80 of 143
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
3. Sex:
Date Location User Value Reason
Sep-16-2020
18:06:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-16-2020
18:06:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LAT
INO(A) OR OF SPANISH
ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-16-2020
18:06:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828003
Page 81 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020
18:07:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828004
Page 82 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-16-2020
18:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 18:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020
18:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828005
Page 83 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 18:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:dislocated sh
oulder
Start Date: UNK/UNK/1
966
Ongoing: NO
End Date:
UNK/UN
K/1967Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 18:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020
10:48:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thank you!
Oct-27-2020
16:51:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828006
Page 84 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-16-2020
11:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Subject has a
history of
Hypertension,
Barrett’s
esophagitis and
GERD recorded
on SDB, this is
not reflected on
Med Hx. Please
revise/update
accordingly.
Thank you.
Sep-16-2020
18:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
dislocated shoulderInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020
18:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1966Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020
18:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1967Initial Entry
1.b
Date Location User Value Reason
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828007
Page 85 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-16-2020 18:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:atrial fibrill
ation
Start Date: UNK/UNK
/1998
Ongoing: YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828008
Page 86 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 18:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
18:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
atrial fibrillationInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020
18:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020
18:09:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-17-2020
13:24:24
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:3Transcription
Error
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828009
Page 87 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada) Medical Hist
ory Term:sleep apn
ea
Start Date: UNK/UN
K/2012
Ongoing: YES
Sep-16-2020
18:10:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:sleep ape
na
Start Date: UNK/UN
K/2012
Ongoing: YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828010
Page 88 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020 18:10:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-17-2020
16:13:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Sep-17-2020
13:24:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Sep-17-2020
13:24:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
sleep
apneaTranscription
Error
Sep-17-2020
01:08:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify SLEEP
APENA as
follows...Should
spelling be
SLEEP
APNEA? If so,
edit as such or
clarify further.
Thank you.
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828011
Page 89 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-16-2020
18:10:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
sleep
apenaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-16-2020
18:10:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020
18:10:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-16-2020 18:12:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:diverticuliti
s
Start Date: UNK/UNK
/2019
Ongoing: YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828012
Page 90 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020 18:12:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020
18:12:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
diverticulitisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-16-2020
18:12:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020
18:12:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-27-2020 16:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828013
Page 91 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Medical Histor
y Term:Hypertensi
on
Start Date: UNK/UNK
/2001
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Oct-27-2020 16:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020
16:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-27-2020
16:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-27-2020
16:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828014
Page 92 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.f
Date Location User Value Reason
Oct-27-2020 16:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:gastroesopha
geal reflux
Start Date: UNK/UNK/2
001
Ongoing: YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828015
Page 93 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.f Line/MH Number:
Date Location User Value Reason
Oct-27-2020 16:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020
16:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
gastroesophageal refluxInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-27-2020
16:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-27-2020
16:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-27-2020 16:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828016
Page 94 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Medical Histo
ry Term:barrett's Eso
phagitus
Start Date: UNK/UNK/
2017
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Oct-27-2020 16:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020
16:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
barrett's EsophagitusInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-27-2020
16:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-27-2020
16:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828017
Page 95 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.h
Date Location User Value Reason
Oct-27-2020 16:51:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Benign Prostat
ic Hypertrophy
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828018
Page 96 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.h Line/MH Number:
Date Location User Value Reason
Oct-27-2020 16:51:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020
16:51:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Benign Prostatic Hypertrop
hyInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-27-2020
16:51:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-27-2020
16:51:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828019
Page 97 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
78.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020
18:15:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828020
Page 98 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-16-2020 18:15:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.5Initial Entry
Sep-16-2020 18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
7.a
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identi
fier::1
Temperature: 98.1
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828021
Page 99 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
18:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828022
Page 100 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-16-2020
18:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-16-2020
18:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
260407Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828023
Page 101 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 18:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 18:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
16:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-17-2020
04:35:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-16-2020
18:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828024
Page 102 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
review and
correct as
appropriate.
Sep-16-2020
18:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
16:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXXMJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
16:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXXMJInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020
16:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXXMKInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828025
Page 103 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b Sample ID
Date Location User Value Reason
Sep-17-2020
16:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXXMKInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020
16:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXXMLInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020
16:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXXMLInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828026
Page 104 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 18:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 18:16:00
(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-17-2020
16:34:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-17-2020
04:35:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-16-2020
18:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828027
Page 105 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
review and
correct as
appropriate.
Sep-16-2020
18:16:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
16:34:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXXMHInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
16:34:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPXXMHInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828028
Page 106 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020
18:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 18:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 18:16:48
(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-16-2020
18:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 13:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 18:16:48
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828029
Page 107 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Sep-16-2020
18:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 18:16:48
(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-16-2020 18:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION 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-16-2020
18:16:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828030
Page 108 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-16-2020
18:16:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLLE
CTED FOR THIS SUBJE
CTInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828031
Page 109 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020
11:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828032
Page 110 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Oct-09-2020
11:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/9/2020Initial Entry
2.a
Date Location User Value Reason
Oct-09-2020
11:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 97.8
Temperature U
nit:F
Temperature L
ocation::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-09-2020
11:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-09-2020
11:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828033
Page 111 of 143
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.a Unit:
Date Location User Value Reason
Oct-09-2020
11:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-09-2020
11:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828034
Page 112 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 11:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 11:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
12:18:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-10-2020
05:20:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-09-2020
11:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0828035
Page 113 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
review and
correct as
appropriate.
Oct-09-2020
11:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
12:18:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW1NZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
12:18:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW1NZInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828036
Page 114 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-09-2020
11:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-09-2020 11:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-09-2020 11:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-09-2020
11:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/9/2020 11:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-09-2020 11:59:05
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828037
Page 115 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Oct-09-2020
11:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-09-2020 11:59:05
(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
Oct-09-2020 11:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Oct-09-2020
11:59:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828038
Page 116 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020
13:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828039
Page 117 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 13:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 13:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-08-2020
10:00:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-07-2020
02:26:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Nov-06-2020
13:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828040
Page 118 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
review and
correct as
appropriate.
Nov-06-2020
13:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-08-2020
10:00:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW1RDInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-08-2020
10:00:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW1RDInitial Entry
5.b
Date Location User Value Reason
Nov-08-2020
10:00:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW1RFInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828041
Page 119 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b Sample ID
Date Location User Value Reason
Nov-08-2020
10:00:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW1RFInitial Entry
5.c
Date Location User Value Reason
Nov-08-2020
10:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW1RGInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-08-2020
10:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW1RGInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828042
Page 120 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-06-2020
13:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-06-2020 13:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-06-2020
13:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828043
Page 121 of 143
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
14:01:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-16-2021
09:19:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Feb-16-2021
09:19:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/22/2020Transcription
Error
Feb-04-2021
11:58:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-03-2021
09:22:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Kindly
review and
complete ‘Further
Vaccination
Confirmation'
form at this visit.
Thank you.
Feb-02-2021
12:17:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Transcription
Error
Feb-02-2021
12:15:09ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828044
Page 122 of 143
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)
Feb-02-2021
12:15:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020New Information
Jan-31-2021
15:42:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Per source,
document,
subject contacted
site to be
unblinded on
16Dec2020.
Please clarify if
this should be
captured here.
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828045
Page 123 of 143
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-16-2021
09:19:51
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-16-2021
09:19:23
(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.
Feb-16-2021
09:19:23
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to r
eturn for Vaccination 3
Participant is:
eligible and NOT conf
irmed to have receive
d only placebo at Vac
cination 1/2Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828046
Page 124 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Oct-09-2020 10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828047
Page 125 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Oct-28-2020 09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828048
Page 126 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Oct-09-2020 10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-09-2020 10:58:02
(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
Oct-30-2020
07:04:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-29-2020
10:28:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dChanged Information
Oct-29-2020
10:28:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
progression of div
erticulitisChanged Information
Oct-29-2020
04:14:25ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020393225,
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828049
Page 127 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00)
Eastern Time (US
& Canada)the event term in SDB was
updated to 'progression of
diverticulitis' while retained
as 'perforated diverticulitis'
in AE CRF.Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Oct-09-2020
10:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
perforated divertic
ulitusInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020
10:30:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Oct-28-2020
10:11:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020
09:09:28ACV0PFEINFP6000 Query 1: Answered Original value is
correct
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828050
Page 128 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00)
Eastern Time (US
& Canada)
Oct-20-2020
13:38:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
clarify if this event
had indeed resolved
on 5Oct20, as
outcome is still
noted as
recovering/resolving.
Oct-09-2020
12:04:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/5/2020 15:00New Information
Oct-09-2020
10:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 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
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828051
Page 129 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Dec-17-2020
10:33:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Response satisfies
query
Dec-16-2020
16:18:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered SAE update
submitted with
additional
symptoms as
requested
Nov-30-2020
15:04:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened In the case narrative
records final
diagnosis for the
case. However,
initial clinical
presentation
(symptoms), it is
not described.
Kindly submit a FU
report with this
information to be
added to the
narrative. Thank
you.
Oct-13-2020
05:13:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-11-2020
10:00:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
perforated
diverticulitus(Onset
date:29Sep2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828052
Page 130 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Oct-09-2020
10:58:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE perforated
diverticulitus:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Oct-09-2020
10:58:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event as
sociated with congenit
al anomaly or birth def
ect?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hosp
italization?
YES
Did this serious event r
esult in persistent or si
gnificant disability/inc
apacity?
NOInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828053
Page 131 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Is this serious event lif
e threatening?
NO
Other medically impor
tant serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is du
e to:
OTHER
If Other, specify:
History of diverticuli
tisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828054
Page 132 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-30-2020
07:03:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Cl
osedResponse satisfies query
Oct-29-2020
10:31:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERI
NG/RESOL
VINGChanged Information
Oct-29-2020
10:30:39
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 3: An
sweredChanged data per query
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828055
Page 133 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(US & Canada)
Oct-29-2020
10:30:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Cl
osedClose Auto Query
Oct-29-2020
10:28:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Op
enedFor AE progression of diverticulitis:
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Oct-28-2020
04:45:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Op
enedSAE
RECON:AER#2020393225,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Oct-27-2020
16:44:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Op
enedFor AE perforated diverticulitus:
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Oct-27-2020
16:44:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Cl
osedClose Auto Query
Oct-27-2020
16:44:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECO
VERED/NO
T RESOLV
EDChanged Information
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828056
Page 134 of 143
***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, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-09-2020
12:04:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Op
enedFor AE perforated diverticulitus:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Oct-09-2020
10:58:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERI
NG/RESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-09-2020
10:58:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-13-2020 05:13:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020393225Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0828057
Page 135 of 143
***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
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 09:12:54
(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
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Pericolonic AbscessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020 ACV0PFEINFP6000 Query 1: Closed Response
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828058
Page 136 of 143
***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
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
12:16:06
(UTC-05:00) Eastern
Time (US & Canada)satisfies query
Nov-09-2020
17:14:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered pericolonic
abscess is still
ongoing.
Nov-09-2020
15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
Please advise on
the status, is this
event still
ongoing?
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020
00:11:28
(UTC-05:00) EasternACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828059
Page 137 of 143
***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
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Pericolonic
Abscess:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event re
quire or prolong hospital
ization?
YES
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828060
Page 138 of 143
***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
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
NO
Other medically importa
nt serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is du
e to:
OTHER
If Other, specify:
related to an underlyi
ng condition reported
in Medical HistoryInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828061
Page 139 of 143
***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
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-30-2020
07:07:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-29-2020
10:33:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dChanged Information
Oct-29-2020
10:33:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DChanged Information
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828062
Page 140 of 143
***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
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-29-2020
04:03:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020393225
,outcome was reported as
Not recovered/Not resolved
to Safety DB
however,recorded as NOT
RECOVERED/NOT
RESOLVED on AE CRF.
Please confirm correct
outcome.If safety update is
required, please submit a
ffup form
Oct-28-2020
09:12:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/R
ESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020
09:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-29-2020 00:11:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020399225Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0828063
Page 141 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-16-2021
09:19:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/22/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-16-2021
09:19:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACC
INATIONInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828064
Page 142 of 143
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-06-2020 13:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-16-2020 18:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Sep-16-2020 18:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-06-2020 13:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/6/2020Initial Entry
Sep-16-2020 18:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020Initial Entry
Sep-16-2020 18:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020Initial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828065
Page 143 of 143
***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, Signed, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-11-2020 15:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
Click Here to EnableInitial Entry
090177e196ae301c\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828066