125742 45 S211 M5 c4591001 1223 12231273

Document text

Page 1 of 520
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497459
Page 2 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/9/2021
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497460
Page 3 of 520
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [12231273]
2.Birth Date: /2005
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:
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497461
Page 4 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/9/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497462
Page 5 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497463
Page 6 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/9/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497464
Page 7 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[seasonal allergies]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497465
Page 8 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497466
Page 9 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/9/2021
2.Weight: [66.4]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [23.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: FOREHEAD
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497467
Page 10 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/9/2021
2.Randomization Number: [26295]
3.Randomization Group: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497468
Page 11 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/9/2021
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 [BPW91R]
5.bSample ID [BPW91S]
5.cSample ID [BPW91T]
5.dSample ID [BRV2NJ]
5.eSample ID [BRV2NK]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497469
Page 12 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/9/2021
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 [BPW914]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497470
Page 13 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/9/2021 10:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497471
Page 14 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497472
Page 15 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497473
Page 16 of 520
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497474
Page 17 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
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
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497475
Page 18 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: RIGHT
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
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497476
Page 19 of 520
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/29/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497477
Page 20 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BR1817]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497478
Page 21 of 520
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/29/2021 15:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497479
Page 22 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497480
Page 23 of 520
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497481
Page 24 of 520
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
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
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497482
Page 25 of 520
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: RIGHT
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
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497483
Page 26 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1883]
5.bSample ID [BR1884]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497484
Page 27 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497485
Page 28 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jun/13/2021
2.Date of First Symptom
Started:Jun/5/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jun/9/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497486
Page 29 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [rhinorrhea]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497487
Page 30 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Jun/13/
2021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497488
Page 31 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jun/13/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: YALE NEW HAVEN HOSPITAL SARS-COV-2 PCR TEST
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497489
Page 32 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Subject was in the emergency room and the hospital did the
test.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497490
Page 33 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[This test was done by hospital staff and they do not have access
to study sample barcodes.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497491
Page 34 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497492
Page 35 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497493
Page 36 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497494
Page 37 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497495
Page 38 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?YES
Respiratory Illness Diagnosis:
[Rhinovirus Infection]
Date of Diagnosis:
Jun/13/2021
3.Toxicity Grade: 2
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497496
Page 39 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497497
Page 40 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497498
Page 41 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497499
Page 42 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497500
Page 43 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497501
Page 44 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497502
Page 45 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Date: Vital Signs Details Form Instance
 1.Jun/13/2021 Record Identifier: Systolic: Diastolic:
1  112  60 Repeating Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497503
Page 46 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jun/13/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [112]
Diastolic: [60]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in
beats/minute:[63]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497504
Page 47 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Date: Vital Signs Details Form Instance
 1.Jun/13/2021 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497505
Page 48 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jun/13/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497506
Page 49 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497507
Page 50 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497508
Page 51 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497509
Page 52 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497510
Page 53 of 520
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.Jun/14/2021  CHEST  MRI  NORMAL  Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497511
Page 54 of 520
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jun/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jun/14/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: MRI
4.Assessment: NORMAL
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497512
Page 55 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497513
Page 56 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497514
Page 57 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497515
Page 58 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497516
Page 59 of 520
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497517
Page 60 of 520
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497518
Page 61 of 520
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497519
Page 62 of 520
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497520
Page 63 of 520
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497521
Page 64 of 520
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497522
Page 65 of 520
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497523
Page 66 of 520
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/7/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497524
Page 67 of 520
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Apr/7/2021Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497525
Page 68 of 520
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? YES
Date of Collection:
Apr/7/2021Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNKYPC]
5.bSample ID [BTFRZZ]
5.cSample ID [BTFS00]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497526
Page 69 of 520
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? YES
Date of Collection:
Apr/7/2021Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ4N0]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497527
Page 70 of 520
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/3/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497528
Page 71 of 520
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/20/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497529
Page 72 of 520
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497530
Page 73 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497531
Page 74 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event S
till OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Myoperica
rditis Jun/12/2021
19:00 NO
End Date Time:
Jun/13/2021 UNK:U
NK
 Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497532
Page 75 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[Myopericarditis]
4.Start Date Time: Jun/12/2021 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/13/2021 UNK:UNK
6.Toxicity Grade: 3
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497533
Page 76 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[Rhinovirus infection]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497534
Page 77 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[2021699328]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497535
Page 78 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497536
Page 79 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497537
Page 80 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
 1.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
 2.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
 3.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
 4.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
 5.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
 6.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
 7.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not App
licable Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497538
Page 81 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497539
Page 82 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497540
Page 83 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497541
Page 84 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497542
Page 85 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497543
Page 86 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497544
Page 87 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497545
Page 88 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not Appl
icable Repeating
Pages
 2.2  CORTICOST
EROIDS NO  prednisone  30  Repeating
Pages
 3.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not Appl
icable Repeating
Pages
 4.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not Appl
icable Repeating
Pages
 5.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not Appl
icable Repeating
Pages
 6.Not Applicabl
e Not Applicab
le Not Applicable  Not Applic
able Not Appl
icable Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497546
Page 89 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497547
Page 90 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497548
Page 91 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[2]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[prednisone]
5.Dose: [30]
6.Dose Unit: mg
7.Dose Frequency: BID
8.Route: ORAL
9.Start Date: Jun/13/2021
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497549
Page 92 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
10.Ongoing? YES
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497550
Page 93 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497551
Page 94 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497552
Page 95 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497553
Page 96 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497554
Page 97 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497555
Page 98 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497556
Page 99 of 520
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497557
Page 100 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497558
Page 101 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497559
Page 102 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497560
Page 103 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497561
Page 104 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497562
Page 105 of 520
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/21/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/21/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497563
Page 106 of 520
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/21/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/21/2021
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 [AA01556]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497564
Page 107 of 520
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on May/05/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/5/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497565
Page 108 of 520
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on May/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/5/2021
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 [AA06954]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497566
Page 109 of 520
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/19/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/19/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497567
Page 110 of 520
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/19/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/19/2021
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 [AA01055]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497568
Page 111 of 520
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/20/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497569
Page 112 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497570
Page 113 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497571
Page 114 of 520
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/21/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497572
Page 115 of 520
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
May/21/2021
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497573
Page 116 of 520
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497574
Page 117 of 520
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :May/21/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497575
Page 118 of 520
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
May/21/2021
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 [BTFS6C]
5.bSample ID [BTFS6D]
5.cSample ID [BTFS6F]
5.dSample ID [ ]
5.eSample ID [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497576
Page 119 of 520
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
May/21/2021
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 [BN1PSL]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497577
Page 120 of 520
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: May/21/2021 13:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497578
Page 121 of 520
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/10/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497579
Page 122 of 520
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/10/2021
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 [BN1PT0]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497580
Page 123 of 520
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jun/10/2021 09:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497581
Page 124 of 520
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/9/2021
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497582
Page 125 of 520
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Jul/9/2021
3.Comments: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497583
Page 126 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497584
Page 127 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497585
Page 128 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497586
Page 129 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497587
Page 130 of 520
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jul/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497588
Page 131 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Mar/3/2021
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497589
Page 132 of 520
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497590
Page 133 of 520
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497591
Page 134 of 520
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-09-2021 11:52:46 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497592
Page 135 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMar-31-2021 18:20:49 (UTC-05:00)
Eastern Time (US & Canada)put in wrong patient
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497593
Page 136 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - Comments
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormApr-12-2021 13:36:39 (UTC-05:00)
Eastern Time (US & Canada)
FormMar-31-2021 18:21:38 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497594
Page 137 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - Comments
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Apr-12-2021 13:36:39 (UTC-05:00)
Eastern Time (US & Canada)
1Mar-31-2021 18:21:38 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497595
Page 138 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormApr-12-2021 13:37:14 (UTC-05:00)
Eastern Time (US & Canada)
FormMar-31-2021 18:22:14 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497596
Page 139 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Apr-12-2021 13:37:14 (UTC-05:00)
Eastern Time (US & Canada)
1Mar-31-2021 18:22:14 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497597
Page 140 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Apr-12-2021 13:37:14 (UTC-05:00)
Eastern Time (US & Canada)
2Mar-31-2021 18:22:14 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497598
Page 141 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Apr-12-2021 13:37:14 (UTC-05:00)
Eastern Time (US & Canada)
3Mar-31-2021 18:22:14 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497599
Page 142 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Apr-12-2021 13:37:14 (UTC-05:00)
Eastern Time (US & Canada)
4Mar-31-2021 18:22:14 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497600
Page 143 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormApr-12-2021 13:37:49 (UTC-05:00)
Eastern Time (US & Canada)
FormMar-31-2021 18:22:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497601
Page 144 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Apr-12-2021 13:37:49 (UTC-05:00)
Eastern Time (US & Canada)
1Mar-31-2021 18:22:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497602
Page 145 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Apr-12-2021 13:37:49 (UTC-05:00)
Eastern Time (US & Canada)
2Mar-31-2021 18:22:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497603
Page 146 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Apr-12-2021 13:37:49 (UTC-05:00)
Eastern Time (US & Canada)
3Mar-31-2021 18:22:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497604
Page 147 of 520
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Apr-12-2021 13:37:49 (UTC-05:00)
Eastern Time (US & Canada)
4Mar-31-2021 18:22:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497605
Page 148 of 520
***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
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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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-21-2021 12:20:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497606
Page 149 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
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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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-21-2021 12:20:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497607
Page 150 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-21-2021 12:20:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497608
Page 151 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-21-2021 12:20:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497609
Page 152 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-21-2021 12:20:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497610
Page 153 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
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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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-21-2021 12:20:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497611
Page 154 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-21-2021 12:22:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497612
Page 155 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-21-2021 12:22:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497613
Page 156 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-21-2021 12:22:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497614
Page 157 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-21-2021 12:22:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497615
Page 158 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-21-2021 12:22:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497616
Page 159 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-21-2021 12:22:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497617
Page 160 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-21-2021 12:23:28 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497618
Page 161 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-21-2021 12:23:28 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497619
Page 162 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-21-2021 12:23:28 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497620
Page 163 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-21-2021 12:23:28 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497621
Page 164 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-21-2021 12:23:28 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497622
Page 165 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-21-2021 12:23:28 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497623
Page 166 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
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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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-21-2021 12:24:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497624
Page 167 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
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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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-21-2021 12:24:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497625
Page 168 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-21-2021 12:24:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497626
Page 169 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
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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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-21-2021 12:24:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497627
Page 170 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-21-2021 12:24:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497628
Page 171 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-21-2021 12:24:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497629
Page 172 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-21-2021 12:25:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497630
Page 173 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-21-2021 12:25:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497631
Page 174 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-21-2021 12:25:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497632
Page 175 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-21-2021 12:25:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497633
Page 176 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-21-2021 12:25:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497634
Page 177 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-21-2021 12:25:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497635
Page 178 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-21-2021 12:26:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497636
Page 179 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-21-2021 12:26:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497637
Page 180 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-21-2021 12:26:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497638
Page 181 of 520
***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-21-2021 12:26:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497639
Page 182 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-21-2021 12:26:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497640
Page 183 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-21-2021 12:26:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497641
Page 184 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-21-2021 12:27:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497642
Page 185 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-21-2021 12:27:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497643
Page 186 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-21-2021 12:27:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497644
Page 187 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-21-2021 12:27:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497645
Page 188 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-21-2021 12:27:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497646
Page 189 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-21-2021 12:27:31 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497647
Page 190 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497648
Page 191 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497649
Page 192 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497650
Page 193 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497651
Page 194 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497652
Page 195 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497653
Page 196 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497654
Page 197 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497655
Page 198 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497656
Page 199 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497657
Page 200 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
10Jun-25-2021 11:32:23 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497658
Page 201 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497659
Page 202 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497660
Page 203 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497661
Page 204 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497662
Page 205 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497663
Page 206 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497664
Page 207 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497665
Page 208 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497666
Page 209 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497667
Page 210 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497668
Page 211 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
10Jun-25-2021 11:34:52 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497669
Page 212 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497670
Page 213 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497671
Page 214 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497672
Page 215 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497673
Page 216 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497674
Page 217 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497675
Page 218 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497676
Page 219 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497677
Page 220 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497678
Page 221 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497679
Page 222 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
10Jun-25-2021 11:37:33 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497680
Page 223 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497681
Page 224 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497682
Page 225 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497683
Page 226 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497684
Page 227 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497685
Page 228 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497686
Page 229 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497687
Page 230 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497688
Page 231 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497689
Page 232 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497690
Page 233 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
10Jun-25-2021 11:39:53 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497691
Page 234 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497692
Page 235 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497693
Page 236 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497694
Page 237 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497695
Page 238 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497696
Page 239 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497697
Page 240 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497698
Page 241 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497699
Page 242 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497700
Page 243 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497701
Page 244 of 520
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED - Comments
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
10Jun-25-2021 11:42:01 (UTC-05:00)
Eastern Time (US & Canada)Anousheh
BehnegarNot Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497702
Page 245 of 520
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-21-2021 14:15:41
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497703
Page 246 of 520
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-31-2021 17:52:07 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica
Tuan Approved Mar-19-2021 21:55:54 (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.
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497704
Page 247 of 520
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 12231273 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jan-09-2021
11:51:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jan-09-2021
11:51:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497705
Page 248 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-09-2021
11:53:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-09-2021
11:52:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Date Informed
Consent
Obtained is not
the same as the
Date of Visit.
Please correct
as necessary.
Jan-09-2021
11:51:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Jan/9/2021Initial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497706
Page 249 of 520
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Jan-09-2021 11:50:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
12231273Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jan-09-2021 11:50:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2005Enrollment Entry
3. Sex:
Date Location User Value Reason
Jan-09-2021
11:51:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jan-09-2021
11:51:56
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH
ORIGINInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497707
Page 250 of 520
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Race: (Check X all that apply):
Date Location User Value Reason
Jan-09-2021
11:51:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497708
Page 251 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-09-2021
11:53:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-09-2021
11:53:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/9/2021Transcription
Error
Jan-09-2021
11:52:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Date of Visit,
09/Feb/2021 is a
future date
relative to when
it was entered on
09/Jan/2021.
Please correct.
Jan-09-2021
11:52:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/9/2021Initial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497709
Page 252 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jan-09-2021
11:53:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/9/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-09-2021 11:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-09-2021
11:53:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497710
Page 253 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Jan-09-2021 11:54:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:seasonal all
ergies
Start Date: UNK/UNK/
2005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-09-2021 11:54:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-09-2021
11:54:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
seasonal allergiesInitial Entry
1.a Start Date:
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497711
Page 254 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-09-2021
11:54:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-09-2021
11:54:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497712
Page 255 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-09-2021
11:54:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497713
Page 256 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/9/2021Initial Entry
2. Weight:
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
66.4Initial Entry
3. Unit:
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497714
Page 257 of 520
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jan-09-2021 11:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
23.2Initial Entry
7.a
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 97.9
Temperature U
nit:FInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497715
Page 258 of 520
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Temperature L
ocation::FOREH
EAD
7.a Record Identifier:
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
7.a Temperature Location:
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497716
Page 259 of 520
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-09-2021
11:56:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FOREHEADInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497717
Page 260 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jan-09-2021
11:56:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/9/2021Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-09-2021
11:56:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
26295Initial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497718
Page 261 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-09-2021 11:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-09-2021 11:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-09-2021
12:55:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-09-2021
11:57:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497719
Page 262 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-09-2021
11:57:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/9/2021Initial Entry
5.a
Date Location User Value Reason
Jan-09-2021
12:55:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BPW91RInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-09-2021
12:55:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BPW91RInitial Entry
5.b
Date Location User Value Reason
Jan-09-2021
12:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BPW91SInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497720
Page 263 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Jan-09-2021
12:55:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BPW91SInitial Entry
5.c
Date Location User Value Reason
Jan-09-2021
12:56:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BPW91TInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-09-2021
12:56:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BPW91TInitial Entry
5.d
Date Location User Value Reason
Jan-11-2021
15:10:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BRV2NJInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497721
Page 264 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.d Sample ID
Date Location User Value Reason
Jan-11-2021
15:10:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BRV2NJInitial Entry
5.e
Date Location User Value Reason
Jan-11-2021
15:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BRV2NKInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-11-2021
15:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BRV2NKInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497722
Page 265 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-09-2021 11:57:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-09-2021 11:57:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021
14:10:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-11-2021
06:28:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0497723
Page 266 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-09-2021
11:57:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-09-2021
11:57:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/9/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021
14:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BPW914Transcription
Error
Jan-11-2021
14:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BPW91FTranscription
Error
Jan-11-2021
14:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
Sample ID: BPW92NInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497724
Page 267 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a Sample ID
Date Location User Value Reason
Jan-11-2021
14:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BPW914Transcription
Error
Jan-11-2021
14:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BPW91FTranscription
Error
Jan-11-2021
14:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Suzana
MuticData Entry:
BPW92NInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497725
Page 268 of 520
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-09-2021
11:58:35
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-09-2021 11:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-09-2021 11:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-09-2021
11:58:35
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
Jan/9/2021 10:25Initial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497726
Page 269 of 520
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Anatomical Location:
Date Location User Value Reason
Jan-09-2021 11:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-09-2021
11:58:35
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Jan-09-2021 11:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-09-2021 11:58:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497727
Page 270 of 520
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-09-2021
11:58:35
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497728
Page 271 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Mar-03-2021
01:50:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed As per site
confirmation -
updated PD
tracker
Mar-02-2021
15:04:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Jessica Tuan Query 1: Answered Diary was not
activated for
vaccination 2
Mar-02-2021
05:17:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened PDQ : Subject is
between 12 to
15 years old,
however e-Diary
data is missing
in trail max
report for
Vaccination 2 ,
Please review
and update as
appropriate else
clarify.
Jan-11-2021
12:16:36
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTE
D FOR THIS SUBJECTTranscription
Error
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497729
Page 272 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
Jan-09-2021
11:58:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLLE
CTED FOR THIS SUBJE
CTInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497730
Page 273 of 520
***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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021
17:46:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/29/2021Initial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497731
Page 274 of 520
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
R
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-29-2021
17:47:33ACV0PF
EINFP60Data Entry:
FEVERInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0497732
Page 275 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00)
Eastern Time (US &
Canada)00 
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
G
UE
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:N
OInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497733
Page 276 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497734
Page 277 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:N
OInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497735
Page 278 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497736
Page 279 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12231273 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-29-2021
17:47:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:NOInitial Entry
090177e19891a037\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0497737
Page 280 of 520
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12231273 Subject Initials: --
…[truncated]