Document text
Page 1 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827177
Page 2 of 201
***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: 12231075 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/2/2020
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827178
Page 3 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Demography
1.Subject ID [12231075]
2.Birth Date: /1965
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:
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827179
Page 4 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827180
Page 5 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827181
Page 6 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827182
Page 7 of 201
***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: 12231075 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:[hypercholesterolemia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[a-fibrullation]
Start Date: UNK/UNK/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Bowel perforation]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Ileostomy]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827183
Page 8 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [63.0]
3.Unit: kg
4.Height: [177.0]
5.Unit: cm
6.Body Mass Index: [20.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827184
Page 9 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [77841]
3.Randomization Group: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827185
Page 10 of 201
***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: 12231075 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/2/2020
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 [BP0XYN]
5.bSample ID [BP0XYP]
5.cSample ID [BP0XYR]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827186
Page 11 of 201
***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: 12231075 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/2/2020
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 [BP0XYM]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827187
Page 12 of 201
***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: 12231075 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/2/2020 09:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827188
Page 13 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827189
Page 14 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827190
Page 15 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827191
Page 16 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827192
Page 17 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827193
Page 18 of 201
***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: 12231075 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/21/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXXP7]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827194
Page 19 of 201
***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: 12231075 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/21/2020 10:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827195
Page 20 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827196
Page 21 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827197
Page 22 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827198
Page 23 of 201
***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: 12231075 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:
Oct/19/2020
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 [BR37PL]
5.bSample ID [BR37PM]
5.cSample ID [BR37PN]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827199
Page 24 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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:
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827200
Page 25 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12231075 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: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827201
Page 26 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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 [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827202
Page 27 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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 [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827203
Page 28 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12231075 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?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827204
Page 29 of 201
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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:
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827205
Page 30 of 201
***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: 12231075 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:
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827206
Page 31 of 201
***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: 12231075 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 [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827207
Page 32 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827208
Page 33 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Unplanned Assessments
1.Assessments
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827209
Page 34 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827210
Page 35 of 201
***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: 12231075 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: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827211
Page 36 of 201
***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: 12231075 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:
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827212
Page 37 of 201
***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: 12231075 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 [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827213
Page 38 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827214
Page 39 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12231075 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:
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827215
Page 40 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12231075 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?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827216
Page 41 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827217
Page 42 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827218
Page 43 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827219
Page 44 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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 per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827220
Page 45 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827221
Page 46 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/18/2020
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827222
Page 47 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827223
Page 48 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827224
Page 49 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12231075 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:
Dec/18/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW8WV]
5.bSample ID [BPW8WW]
5.cSample ID [BPW8WX]
5.dSample ID [BRV2MP]
5.eSample ID [BRV2MR]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827225
Page 50 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12231075 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:
Dec/18/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW8WT]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827226
Page 51 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/18/2020 11:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827227
Page 52 of 201
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827228
Page 53 of 201
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12231075 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:
Jan/6/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW8ZW]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827229
Page 54 of 201
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/6/2021 12:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827230
Page 55 of 201
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827231
Page 56 of 201
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/3/2021
3.Comments: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827232
Page 57 of 201
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827233
Page 58 of 201
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827234
Page 59 of 201
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827235
Page 60 of 201
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827236
Page 61 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Feb/3/2021 Comments
2.Phase of Disposition: OPEN LABEL TREATMENT Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827237
Page 62 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 intermittent headache
s Jan/7/2021 19:30 NO
End Date Time:
Jan/26/2021 08:00
Repeating
Pages
2.ADVERSE EVE
NT 2 chills Jan/6/2021 23:00 NO
End Date Time:
Jan/6/2021 23:30
Repeating
Pages
3.ADVERSE EVE
NT 3 myalgia Jan/6/2021 23:00 NO
End Date Time:
Jan/6/2021 23:30
Repeating
Pages
4.ADVERSE EVE
NT 4 Bowel necrosis Feb/4/2021 00:00 NO
End Date Time:
UNK/UNK/2021 UNK:UN
K
Repeating
Pages
5.ADVERSE EVE
NT 5 Small Bowel Obstruct
ion Feb/16/2021 UNK:U
NK NO
End Date Time:
Feb/19/2021 UNK:UNK
Repeating
Pages
6.ADVERSE EVE
NT 6 Postoperative ileus Feb/11/2021 UNK:U
NK NO
End Date Time:
Feb/15/2021 UNK:UNK
Repeating
Pages
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827238
Page 63 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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)[intermittent headaches]
4.Start Date Time: Jan/7/2021 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/26/2021 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827239
Page 64 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827240
Page 65 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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)[chills]
4.Start Date Time: Jan/6/2021 23:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 23:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827241
Page 66 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827242
Page 67 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[myalgia]
4.Start Date Time: Jan/6/2021 23:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 23:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827243
Page 68 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827244
Page 69 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Bowel necrosis]
4.Start Date Time: Feb/4/2021 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
UNK/UNK/2021 UNK:UNK
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?
YES
Is this serious event life threatening?
YES
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[History of Bowel perforation]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827245
Page 70 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021218814]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827246
Page 71 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Small Bowel Obstruction]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/19/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
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?
YES
Is this serious event life threatening?
YES
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Postoperative complication]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827247
Page 72 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021218814]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827248
Page 73 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Postoperative ileus]
4.Start Date Time: Feb/11/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/15/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
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?
YES
Is this serious event life threatening?
YES
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Postoperative complication]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827249
Page 74 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021218814]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827250
Page 75 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
1. Repeating Pages
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827251
Page 76 of 201
***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: 12231075 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[ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827252
Page 77 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Dat
eForm Instance
1.1 VACCINATIONS NO influenza vaccine
Oct/9/20
20 Repeating
Pages
2.2 VACCINATIONS NO shingrix vaccine Oct/9/20
20 Repeating
Pages
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827253
Page 78 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[influenza vaccine]
5.Date: Oct/9/2020
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827254
Page 79 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[shingrix vaccine]
5.Date: Oct/9/2020
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827255
Page 80 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827256
Page 81 of 201
***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: 12231075 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?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827257
Page 82 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827258
Page 83 of 201
***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: 12231075 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?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827259
Page 84 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827260
Page 85 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827261
Page 86 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827262
Page 87 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827263
Page 88 of 201
***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: 12231075 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: [ ]
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827264
Page 89 of 201
***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: 12231075 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 Oct/19/2020
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827265
Page 90 of 201
***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: 12231075 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
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827266
Page 91 of 201
***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: 12231075 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-23-2021 14:32:06 (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.
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827267
Page 92 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormSep-02-2020 19:58:23 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827268
Page 93 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormDec-18-2020 16:32:52 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827269
Page 94 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormMar-02-2021 15:23:20 (UTC-05:00) Eastern Time
(US & Canada)
FormJan-28-2021 11:15:12 (UTC-05:00) Eastern Time
(US & Canada)data entered in error
Not Applicable
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827270
Page 95 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1Mar-02-2021 15:23:20 (UTC-05:00) Eastern Time
(US & Canada)
1Jan-28-2021 11:15:12 (UTC-05:00) Eastern Time (US
& Canada)data entered in error
Not Applicable
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827271
Page 96 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
2Mar-02-2021 15:23:20 (UTC-05:00) Eastern Time
(US & Canada)
2Jan-28-2021 11:15:12 (UTC-05:00) Eastern Time (US
& Canada)data entered in error
Not Applicable
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827272
Page 97 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
3Mar-02-2021 15:23:20 (UTC-05:00) Eastern Time
(US & Canada)
3Jan-28-2021 11:15:12 (UTC-05:00) Eastern Time (US
& Canada)data entered in error
Not Applicable
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827273
Page 98 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
4Mar-02-2021 15:23:20 (UTC-05:00) Eastern Time
(US & Canada)
4Jan-28-2021 11:15:12 (UTC-05:00) Eastern Time (US
& Canada)data entered in error
Not Applicable
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827274
Page 99 of 201
***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: 12231075 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-23-2021 14:32:06 (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 Jan-27-2021 08:56:51 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica Tuan Approved Jan-21-2021 14:00:54 (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 Dec-18-2020 16:31:49 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Onyema
Ogbuagu Approved Oct-29-2020 18:18:34 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827275
Page 100 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Affidavit:
By my dated signature below, I, OnyemaOgbuagu, 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.
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827276
Page 101 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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-02-2020 19:57:29
(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-02-2020 19:57:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827277
Page 102 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020 19:57:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/2/2020Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827278
Page 103 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020 19:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12231075Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020 19:55:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020 19:57:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020 19:57:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020 19:57:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827279
Page 104 of 201
***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: 12231075 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-02-2020 19:58:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827280
Page 105 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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-02-2020 19:58:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020 19:58:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020 19:58:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827281
Page 106 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020 19:59:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:hypercholesterole
mia
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020 19:59:57
(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
Mar-13-2021 03:40:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Deleted bowel perforation
added
Mar-09-2021 11:50:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Candidate Please do not freeze.
AE of bowel
perforation to be
added per SAE query
response
Sep-02-2020 19:59:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypercholesterolemiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-02-2020 19:59:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020 19:59:57
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0827282
Page 107 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(US & Canada)
1.b
Date Location User Value Reason
Sep-02-2020 20:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:a-fibrullation
Start Date: UNK/UNK/201
4
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 20:00:36
(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-02-2020 20:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
a-fibrullationInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 20:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 20:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Mar-09-2021 15:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827283
Page 108 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Medical History Te
rm:Bowel perforation
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/20
10
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827284
Page 109 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.c Line/MH Number:
Date Location User Value Reason
Mar-09-2021 15:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-12-2021 10:28:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-11-2021 16:37:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanQuery 1: Answered Changed data per query
Mar-11-2021 15:54:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Bowel
Perforation is noted in
2010. However, there is
no corresponding
treatment. Please
confirm the treatment
and if surgical, update
the CRF as appropriate.
Mar-09-2021 15:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
Bowel perforationInitial Entry
1.c Start Date:
Date Location User Value Reason
Mar-09-2021 15:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Mar-09-2021 15:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.d
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827285
Page 110 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Mar-11-2021 16:36:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Ileostomy
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/20
10Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Mar-11-2021 16:36:29
(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
Mar-11-2021 16:36:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
IleostomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Mar-11-2021 16:36:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Mar-11-2021 16:36:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827286
Page 111 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
63.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
177.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20.1Initial Entry
7.a
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827287
Page 112 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 20:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827288
Page 113 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020 20:04:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020 20:04:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
77841Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827289
Page 114 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 20:04:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 20:04:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 10:34:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 09:21:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query: 'Sample
Collected?' is Yes,
however no barcodes
are entered. Please
review and correct as
appropriate.
Sep-02-2020 20:04:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-02-2020 20:04:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 10:34:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0XYNInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827290
Page 115 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 10:34:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP0XYNInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 10:34:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0XYPInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020 10:34:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP0XYPInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 10:34:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0XYRInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-04-2020 10:34:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP0XYRInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827291
Page 116 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 20:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 20:04:42
(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-04-2020 11:42:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 09:21:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query: 'Sample
Collected?' is Yes,
however no barcodes
are entered. Please
review and correct as
appropriate.
Sep-02-2020 20:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-02-2020 20:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 11:42:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0XYMInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),
(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827292
Page 117 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 11:42:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP0XYMInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827293
Page 118 of 201
***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: 12231075 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-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 09:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827294
Page 119 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-03-2020 15:21:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827295
Page 120 of 201
***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: 12231075 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-02-2020 20:04:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827296
Page 121 of 201
***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: 12231075 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-21-2020 15:09:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0827297
Page 122 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827298
Page 123 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.b Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827299
Page 124 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827300
Page 125 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827301
Page 126 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.g Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827302
Page 127 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4. Injection Site Body Side:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827303
Page 128 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 16:31:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827304
Page 129 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 15:10:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 15:10:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Location:
:FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 15:10:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-21-2020 15:10:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020 15:10:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 15:10:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827305
Page 130 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 15:10:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 15:10:55
(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-22-2020 10:11:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 03:37:20
(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-21-2020 15:10:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-21-2020 15:10:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020 10:11:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXXP7Initial Entry
5.a Sample ID
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827306
Page 131 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Sep-22-2020 10:11:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPXXP7Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827307
Page 132 of 201
***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: 12231075 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-21-2020 15:11:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 15:11:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 15:11:44
(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-21-2020 15:11:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020 10:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 15:11:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-21-2020 15:11:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827308
Page 133 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-21-2020 15:11:44
(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-21-2020 15:11:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-21-2020 15:11:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827309
Page 134 of 201
***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: 12231075 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-19-2020 13:10:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827310
Page 135 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827311
Page 136 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.b Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827312
Page 137 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827313
Page 138 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827314
Page 139 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
2.g Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827315
Page 140 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4. Injection Site Body Side:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827316
Page 141 of 201
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-20-2020 13:41:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827317
Page 142 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 13:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 13:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 14:35:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-20-2020 09:45:16
(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-19-2020 13:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-19-2020 13:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 14:35:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR37PLInitial Entry
5.a Sample ID
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827318
Page 143 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Oct-20-2020 14:35:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR37PLInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 14:35:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR37PMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 14:35:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR37PMInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 14:35:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR37PNInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 14:35:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BR37PNInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827319
Page 144 of 201
***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: 12231075 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
Oct-19-2020 13:10:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 13:10:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 13:10:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827320
Page 145 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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-25-2021 09:34:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Transcription Error
Dec-18-2020 16:31:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827321
Page 146 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
Jan-04-2021 18:47:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-21-2020 03:17:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Dec-18-2020 16:32:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Dec-18-2020 16:32:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per local/national recomme
ndations and confirmed to have rec
eived only placebo at Vaccination
1/2Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827322
Page 147 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 16:34:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-18-2020 16:34:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Transcription Error
Dec-18-2020 16:32:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Visit is before
the Date Written
Consent Obtained.
Please review and
update as appropriate.
Dec-18-2020 16:32:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/18/2020Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827323
Page 148 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-18-2020 16:34:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-18-2020 16:32:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Dec-18-2020 16:32:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/18/2020Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827324
Page 149 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
Dec-18-2020 16:33:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-18-2020 16:33:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020 16:33:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827325
Page 150 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 16:34:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 16:34:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-20-2020 10:38:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 16:34:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-18-2020 16:34:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-20-2020 10:38:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
Sample ID: BPW8WVInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-20-2020 10:38:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
BPW8WVInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827326
Page 151 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b
Date Location User Value Reason
Dec-20-2020 10:39:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
Sample ID: BPW8WWInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-20-2020 10:39:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
BPW8WWInitial Entry
5.c
Date Location User Value Reason
Dec-20-2020 10:39:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
Sample ID: BPW8WXInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-20-2020 10:39:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
BPW8WXInitial Entry
5.d
Date Location User Value Reason
Dec-20-2020 10:40:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
Sample ID: BRV2MPInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-20-2020 10:40:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
BRV2MPInitial Entry
5.e
Date Location User Value Reason
Dec-20-2020 10:40:20
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Suzana
MuticData Entry:
Sample ID: BRV2MRInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827327
Page 152 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(US & Canada)
5.e Sample ID
Date Location User Value Reason
Dec-20-2020 10:40:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
BRV2MRInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827328
Page 153 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 16:35:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 16:35:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-20-2020 11:16:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 16:35:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-18-2020 16:35:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-20-2020 11:16:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
Sample ID: BPW8WTInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-20-2020 11:16:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
BPW8WTInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827329
Page 154 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020 11:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827330
Page 155 of 201
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-18-2020 16:36:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827331
Page 156 of 201
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021 19:03:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827332
Page 157 of 201
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021 12:09:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-06-2021 12:09:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021 12:09:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-06-2021 12:09:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-06-2021 12:09:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
YES
Date of Collection:
Jan/6/2021Initial Entry
5.a
Date Location User Value Reason
Jan-06-2021 12:09:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
Sample ID: BPW8ZWInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-06-2021 12:09:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Suzana
MuticData Entry:
BPW8ZWInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827333
Page 158 of 201
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021 12:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827334
Page 159 of 201
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-06-2021 19:04:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827335
Page 160 of 201
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-02-2021
22:02:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation Check:
VC_SV001_11
Mar-02-2021
15:24:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredChanged data per query
Mar-01-2021
08:21:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7482275;V103 Visit Date is
entered, but Disposition -
Treatment form at
FURTHER_VACCINATION_EOT
visit is not completed. Please
review and update as appropriate.
Feb-26-2021
14:51:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/3/
2021Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827336
Page 161 of 201
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-26-2021 14:51:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-26-2021 14:51:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/3/2021Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827337
Page 162 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 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
Mar-04-2021
06:38:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Close
dincorrect query
Mar-03-2021
03:20:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Open
edDMW7580942;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Mar-02-2021
15:23:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/3/2021Initial Entry
Mar-02-2021
15:23:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-28-2021
15:55:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Close
dAuto closed by
Validation Check:
VC_DS001_21
Jan-28-2021
11:15:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not Applicabl
eInitial Entry
Jan-28-2021
11:14:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredChanged Information
Jan-28-2021
11:14:45ACV0PFEINFP6000 Data Entry: Changed Information
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827338
Page 163 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00)
Eastern Time
(US & Canada)
Jan-27-2021
15:37:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Open
edDMW7034181;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Jan-27-2021
08:56:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-02-2021 15:23:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
Mar-02-2021 15:23:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
Jan-28-2021 11:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Jan-28-2021 11:14:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Jan-27-2021 08:56:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-02-2021 15:23:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
Mar-02-2021 15:23:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827339
Page 164 of 201
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Jan-28-2021 11:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-28-2021 11:14:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Jan-27-2021 08:56:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-02-2021 15:23:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-28-2021 11:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827340
Page 165 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827341
Page 166 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827342
Page 167 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827343
Page 168 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanForm Created
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827344
Page 169 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanForm Created
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827345
Page 170 of 201
***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: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Mar-11-2021 16:26:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanForm Created
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827346
Page 171 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-22-2021 03:56:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sohil Patel Query 1: Closed Response satisfies
query
Mar-12-2021 13:19:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Mar-12-2021 13:19:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
intermittent headachesTranscription Error
Mar-12-2021 12:09:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sohil Patel Query 1: Opened Clin: please clarify if
these were continuous
or intermittent
headaches and update
AE as appropriate
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
headachesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021 19:30Initial Entry
5. Is the adverse event still ongoing?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827347
Page 172 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/26/2021 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-26-2021 17:02:44
(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
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827348
Page 173 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-26-2021 17:02:44
(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
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-26-2021 17:02:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827349
Page 174 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021 23:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/6/2021 23:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827350
Page 175 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-26-2021 17:05:12
(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
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827351
Page 176 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-26-2021 17:05:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827352
Page 177 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
myalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021 23:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/6/2021 23:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827353
Page 178 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-26-2021 17:06:41
(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
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0827354
Page 179 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-26-2021 17:06:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827355
Page 180 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021 14:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Mar-11-2021 16:28:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica Tuan Query 1: Answered Changed data per
query
Mar-11-2021 05:39:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical monitor_ Per
report, the subject
"postoperative ileus on
11Feb2021, and CT
ab/pelvis which
showed small bowel
obstruction". Pls revise
and update log for
additional SAEs.
Thanks.
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica Tuan Data Entry:
Bowel necrosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
Feb/4/2021 00:00Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827356
Page 181 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NO
End Date Time:
UNK/UNK/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021 17:48:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Closed Response satisfies
query
Mar-05-2021 10:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Mar-05-2021 10:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
4Changed Information
Mar-04-2021 18:48:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Samuel
DychterQuery 1: Opened GPD Clin: Grade 3
toxicity is not
congruent with
life-threatening, as per
the SAE criteria. Please
re-confirm.
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-03-2021 06:24:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Bowel
necrosis: Response to
"Is the adverse event
serious?" is 'Yes' but
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827357
Page 182 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
"Serious Adverse
Event Number" is
blank.
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
YES
Is this serious event associated with co
ngenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolon
g hospitalization?
YES
Did this serious event result in persiste
nt or significant disability/incapacity?
YES
Is this serious event life threatening?
YES
Other medically important serious eve
nt
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-10-2021
22:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Samuel Dychter Query 1: Closed Response satisfies
query
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827358
Page 183 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Mar-10-2021
04:01:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-09-2021
15:14:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jessica Tuan Query 2: Answer
edChanged data per
query
Mar-09-2021
11:51:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissue
d:OpenedDM: Medical
History form
unfrozen. Please
review and
update
accordingly.
Mar-05-2021
10:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edYes, history of
bowel perforation
is to be added and
CRF should be
unlocked.
Mar-05-2021
10:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edYes, history of
bowel perforation
is to be added and
CRF should be
unlocked.
Mar-05-2021
10:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jessica Tuan Data Entry:
NOT RELATED
If Not Related t
o study treatme
nt(s), this event
is due to:
OTHER
If Other, spe
cify:
History of
Bowel perf
orationYes, history of
bowel perforation
is to be added and
CRF should be
unlocked.
Mar-05-2021
00:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 2: Opened Please review "If
not related to
study treatment
other" field, the
following text
was indicated in
the comment field
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827359
Page 184 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
[Bowel
perforation]. Any
symptoms, AEs
or other key data
should be
collected on the
appropriate page.
Please review and
update as
necessary.
Mar-04-2021
08:22:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Samuel Dychter Query 1: Opened GPD Clin: A
medical history of
bowel perforation
is not listed.
Please confirm
that is to be added
and the CRF will
be unlocked.
Mar-02-2021
14:09:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Jessica Tuan Data Entry:
NOT RELATED
If Not Related t
o study treatme
nt(s), this event
is due to:
OTHER
If Other, spe
cify:
History of
Bowel perf
orationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
YESInitial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827360
Page 185 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
RECOVERED/RESOLVED WITH SEQ
UELAEInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-02-2021 14:09:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-03-2021 06:24:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2021218814Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827361
Page 186 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
Small Bowel ObstructionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
Feb/16/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NO
End Date Time:
Feb/19/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
3Initial Entry
7. Is the adverse event serious?
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827362
Page 187 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-16-2021 05:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed SDB updated
Mar-15-2021 16:00:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Small Bowel
Obstruction is not
reported to Safety
database but marked
serious on AE CRF. Per
query response, please
re-submit SAE follow
up form to update
safety database.
Mar-15-2021 15:56:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Updated in SDB
Mar-15-2021 09:07:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanQuery 2: Answered It was reported to
safety database already
and electronically sent
to the SAE mailbox.
Mar-14-2021 10:58:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON: Small
Bowel Obstruction is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event on
AE CRF
Mar-14-2021 10:58:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Deleted NOT YER
REPORTED IN SDB
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Small Bowel
Obstruction: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827363
Page 188 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
YES
Is this serious event associated with co
ngenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolo
ng hospitalization?
YES
Did this serious event result in persiste
nt or significant disability/incapacity?
YES
Is this serious event life threatening?
YES
Other medically important serious eve
nt
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 16:22:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOT RELATED
If Not Related to study treatment(s), thi
s event is due to:
OTHER
If Other, specify:
Postoperative complicationChanged Information
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827364
Page 189 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 16:22:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
TuanData Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-16-2021 05:26:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2021218814Initial Entry
090177e196ae3017\Final\Final On: 01-Apr-2021 04:00 (GMT)
…[truncated]