Document text
Page 1 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496062
Page 2 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Dec/12/2020
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496063
Page 3 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [11471281]
2.Birth Date: 2007
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:
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0496064
Page 4 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/12/2020
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496065
Page 5 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496066
Page 6 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathDec/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496067
Page 7 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Constipation]
Start Date: Jul/2/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Psoriasis]
Start Date: UNK/UNK/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Perforation of right tympanic membrane]
Start Date: Jul/2/2014
Ongoing: YES
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496068
Page 8 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Other iron deficiency anemia]
Start Date: May/27/2020
Ongoing: YES
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496069
Page 9 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496070
Page 10 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Dec/12/2020
2.Weight: [67.65]
3.Unit: kg
4.Height: [172.5]
5.Unit: cm
6.Body Mass Index: [22.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496071
Page 11 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Dec/12/2020
2.Randomization Number: [22214]
3.Randomization Group: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496072
Page 12 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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:
Dec/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8H52]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496073
Page 13 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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:
Dec/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8H5C]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496074
Page 14 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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: Dec/12/2020 10:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496075
Page 15 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496076
Page 16 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496077
Page 17 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496078
Page 18 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496079
Page 19 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496080
Page 20 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/4/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496081
Page 21 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/4/2021
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 [BP8HDN]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496082
Page 22 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/4/2021 16:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496083
Page 23 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/6/2021
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496084
Page 24 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?YES
Ongoing?
NO
Stop Date:
Jan/9/2021
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Jan/9/2021
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496085
Page 25 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?YES
Ongoing?
NO
Stop Date:
Jan/9/2021
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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496086
Page 26 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496087
Page 27 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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:
Feb/6/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSGV4N]
5.bSample ID [BR5J35]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496088
Page 28 of 216
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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:
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496089
Page 29 of 216
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496090
Page 30 of 216
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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 [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496091
Page 31 of 216
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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 [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496092
Page 32 of 216
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496093
Page 33 of 216
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496094
Page 34 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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:
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496095
Page 35 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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 [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496096
Page 36 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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:
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496097
Page 37 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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 [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496098
Page 38 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496099
Page 39 of 216
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496100
Page 40 of 216
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496101
Page 41 of 216
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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:
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496102
Page 42 of 216
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496103
Page 43 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496104
Page 44 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496105
Page 45 of 216
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Feb/6/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496106
Page 46 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/10/2021
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496107
Page 47 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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 local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496108
Page 48 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496109
Page 49 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Id
entifie
rAdverse EventStart Da
teIs the Adverse Ev
ent Still OngoingForm Insta
nce
1.ADVERS
E EVENT
1 Acute appendicitis Jan/22/2
021 16:0
0 NO
End Date Time:
Jan/23/2021 00
:01
Repeating
Pages
2.ADVERS
E EVENT
2 localized peritonitis, wit
hout perforation or gangr
ene Jan/22/2
021 16:0
0 NO
End Date Time:
Jan/23/2021 00
:01
Repeating
Pages
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496110
Page 50 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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)[Acute appendicitis]
4.Start Date Time: Jan/22/2021 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/23/2021 00:01
6.Toxicity Grade: 4
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496111
Page 51 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?
YES
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Acute appendicitis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496112
Page 52 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021104203]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496113
Page 53 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[localized peritonitis, without perforation or gangrene]
4.Start Date Time: Jan/22/2021 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/23/2021 00:01
6.Toxicity Grade: 4
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496114
Page 54 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Acute appendicitis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496115
Page 55 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021104203]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496116
Page 56 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496117
Page 57 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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[ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496118
Page 58 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496119
Page 59 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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.Date: //
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496120
Page 60 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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. Repeating
Pages
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496121
Page 61 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496122
Page 62 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496123
Page 63 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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?
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496124
Page 64 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496125
Page 65 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496126
Page 66 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496127
Page 67 of 216
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496128
Page 68 of 216
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496129
Page 69 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/14/2021
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496130
Page 70 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/14/2021
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496131
Page 71 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496132
Page 72 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496133
Page 73 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/14/2021
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 [BV1K43]
5.bSample ID [BV1K44]
5.cSample ID [BSC42G]
5.dSample ID [BSC42V]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496134
Page 74 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/14/2021
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 [BV1K3D]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496135
Page 75 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/14/2021 14:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496136
Page 76 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/3/2021
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496137
Page 77 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/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 [BV1K5H]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496138
Page 78 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/3/2021 10:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496139
Page 79 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/7/2021
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496140
Page 80 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/7/2021
3.Comments: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496141
Page 81 of 216
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496142
Page 82 of 216
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496143
Page 83 of 216
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496144
Page 84 of 216
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496145
Page 85 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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/7/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496146
Page 86 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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 Feb/6/2021
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496147
Page 87 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496148
Page 88 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496149
Page 89 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormDec-13-2020 14:17:40 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496150
Page 90 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMar-05-2021 13:02:09
(UTC-06:00) Central Time (US &
Canada)James
McMullen
FormDec-13-2020 14:22:35
(UTC-06:00) Central Time (US &
Canada)Not Applicable
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496151
Page 91 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-17-2021 21:23:19 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496152
Page 92 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Fredrick
Okwori N/A May-13-2021 16:01:52 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Mar-18-2021 20:50:51 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JuliaGarcia-Diaz, 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.
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496153
Page 93 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Dec-13-2020
14:06:16
(UTC-06:00) Central
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
Dec-13-2020
14:06:16
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496154
Page 94 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-13-2020
14:06:43
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Dec/12/2020Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496155
Page 95 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-13-2020
14:06:04
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
11471281Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Dec-13-2020
14:05:55
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
/2007Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-13-2020
14:17:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Dec-13-2020
14:17:07ACV0PF
EINFP60Data Entry:
NOT HISPANIC OR LATIInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
FDA-CBER-2022-5812-0496156
Page 96 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US &
Canada)00 NO(A) OR OF SPANISH
ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-13-2020
14:17:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
6. Racial Designation:
Date Location User Value Reason
Jan-26-2021
23:36:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Jan-26-2021
13:15:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answere
dChanged Information
Jan-26-2021
13:15:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry: Changed Information
090177e19891a03c\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-2022-5812-0496157
Page 97 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021
04:34:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 2: Closed duplicate query
Jan-25-2021
03:58:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued
:OpenedDM: If participant
does not identify as
ASIAN, please leave
the Racial
Designation field
BLANK. Thank you.
Jan-22-2021
12:08:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 2: Answere
dnon Asian
Jan-22-2021
12:07:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answere
dnon asian
Jan-21-2021
10:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 2: Opened DMW6937996;Racial
Designation is
updated, however
Race is not ASIAN.
Please review and
update appropriately
or clarify.
Jan-21-2021
09:14:10
(UTC-06:00)
Central Time (USACV0PF
EINFP60
00.InFor
mAdapteDMW QUERY Query 1: Opened DMW6937996;Racial
Designation is
updated, however
Race is not ASIAN.
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496158
Page 98 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) r.Discrep
ancy Please review and
update appropriately
or clarify.
Dec-13-2020
14:46:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
OTHERInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496159
Page 99 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-13-2020
14:17:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/12/2020Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496160
Page 100 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Dec-13-2020
14:17:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-13-2020
14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Dec-13-2020
14:17:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496161
Page 101 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Mar-05-2021
13:03:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Constipat
ion
Start Date: Jul/2/201
4
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Mar-05-2021
13:03:11
(UTC-06:00) Central
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
Mar-05-2021
13:03:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
ConstipationInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496162
Page 102 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.a Start Date:
Date Location User Value Reason
Mar-05-2021
13:03:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jul/2/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Mar-05-2021
13:03:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Mar-05-2021
13:07:06
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical Histor
y Term:Psoriasis
Start Date: UNK/UNK
/2016
Ongoing: YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496163
Page 103 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Mar-05-2021
13:07:06
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-10-2021
09:40:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Mar-10-2021
08:18:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Correct. Site is
confirming via
medical records
that subject did not
receive
corticosteroids or
other
immunosuppressive
medications for
psoriasis
Mar-09-2021
09:14:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:Ope
nedTo clarify - site is
confirming that
participant DID
NOT receive
systemic
corticosteroids or
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496164
Page 104 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
other
immunosuppressive
medications for
psoriasis? Thank
you
Mar-09-2021
08:36:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Confirmed via
medical records
Mar-08-2021
07:59:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Opened GPD Clin: please
confirm if
participant did/did
not receive
systemic
corticosteroids or
other
immunosuppressive
medications for
psoriasis within
28d prior to or
during study
treatment period.
Mar-05-2021
13:07:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
PsoriasisInitial Entry
1.b Start Date:
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0496165
Page 105 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-05-2021
13:07:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Mar-05-2021
13:07:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Mar-05-2021
13:07:33
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Perforation of rig
ht tympanic mem
brane
Start Date
:Jul/2/2014
Ongoing: YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496166
Page 106 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.c Line/MH Number:
Date Location User Value Reason
Mar-05-2021
13:07:33
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-05-2021
13:07:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Perforation of right tympa
nic membraneInitial Entry
1.c Start Date:
Date Location User Value Reason
Mar-05-2021
13:07:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jul/2/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Mar-05-2021
13:07:33
(UTC-06:00)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496167
Page 107 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)
1.d
Date Location User Value Reason
Mar-05-2021
13:09:06
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Other iron defi
ciency anemia
Start Date: May/27/2020
Ongoing: YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496168
Page 108 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.d Line/MH Number:
Date Location User Value Reason
Mar-05-2021
13:09:06
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-09-2021
14:23:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-09-2021
08:36:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Confirmed that
the subject did
not receive any
blood products
within 60 days
prior to
enrollment
Mar-08-2021
09:17:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened ClinQuery:
Other Iron
Deficiency
Anemia
reported: Please
confirm if
subject has
received any
blood products
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496169
Page 109 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
within 60 days
before
enrollment.
Mar-05-2021
13:09:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Other iron deficiency ane
miaInitial Entry
1.d Start Date:
Date Location User Value Reason
Mar-05-2021
13:09:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
May/27/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Mar-05-2021
13:09:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496170
Page 110 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Mar-08-2021
16:55:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Closed Response
satisfies query
Mar-05-2021
13:21:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Medhx updated
Mar-04-2021
05:05:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Reissued:Opene
dPls revise and
update form
accordingly.
Feb-23-2021
17:47:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered MedHx is
frozen.
Feb-22-2021
02:09:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Reissued:Opene
dMed Hx has
been unfrozen.
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496171
Page 111 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-19-2021
11:23:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Reissued:Candid
ateMed Hx has
been unfrozen.
Feb-15-2021
11:15:26
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered MedHx is not
unfrozen. Please
unfreeze.
Feb-15-2021
03:32:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Reissued:Opene
dUnfrozen,
kindly update.
Thanks
Feb-13-2021
07:31:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Reissued:Candid
ateUnfrozen.
Thanks
Feb-05-2021
13:49:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Please unfreeze
Feb-03-2021
16:29:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Opened Clinical_ Per
report, the
subject has
"MedHx_
psoriasis,
perforation of
right tympanic
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496172
Page 112 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
membrane,
anemia and
constipation."
However, this
additional
information is
missing on
MEDHX form
of CRF. Pls
revise and
update form
accordingly.
Thanks.
Dec-13-2020
14:22:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT know
n to be HIV POSITIVEInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496173
Page 113 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
67.65Initial Entry
3. Unit:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e19891a03c\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-2022-5812-0496174
Page 114 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
172.5Initial Entry
5. Unit:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
22.7Initial Entry
7.a
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identif
ier::1
Temperature: 98.0
Temperature
Unit:FInitial Entry
090177e19891a03c\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-2022-5812-0496175
Page 115 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Temperature
Location::ORAL C
AVITY
7.a Record Identifier:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
7.a Temperature Location:
090177e19891a03c\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-2022-5812-0496176
Page 116 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Dec-13-2020
14:24:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496177
Page 117 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Dec-13-2020
14:25:50
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Dec-13-2020
14:25:50
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
22214Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496178
Page 118 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-13-2020
14:26:00
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-13-2020
14:26:00
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-14-2020
08:13:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Dec-14-2020
04:52:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496179
Page 119 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Dec-13-2020
14:26:00
(UTC-06:00)
Central 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.
Dec-13-2020
14:26:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/12/2020Initial Entry
5.a
Date Location User Value Reason
Dec-14-2020
08:13:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8H52Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-14-2020
08:13:04
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
BP8H52Initial Entry
090177e19891a03c\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-2022-5812-0496180
Page 120 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US &
Canada)
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496181
Page 121 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-13-2020
14:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-13-2020
14:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-14-2020
08:05:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Dec-14-2020
04:52:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496182
Page 122 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Dec-13-2020
14:26:09
(UTC-06:00)
Central 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.
Dec-13-2020
14:26:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/12/2020Initial Entry
5.a
Date Location User Value Reason
Dec-14-2020
08:05:11
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8H5CInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-14-2020
08:05:11
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
BP8H5CInitial Entry
090177e19891a03c\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-2022-5812-0496183
Page 123 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US &
Canada)
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496184
Page 124 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-13-2020
14:26:46ACV0PF
EINFP60Data Entry:
Dec/12/2020 10:44Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496185
Page 125 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US &
Canada)00
5. Anatomical Location:
Date Location User Value Reason
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496186
Page 126 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Dec-13-2020
14:26:46
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496187
Page 127 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Dec-13-2020
14:26:53
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTED
FOR THIS SUBJECTInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496188
Page 128 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021
20:46:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Veronica
GonzalezQuery 1: Closed Response
satisfies query
Feb-02-2021
17:16:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered ICF and IAF
attached to visit
on 04JAN2021.
Documents
corrected
Jan-31-2021
23:53:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Veronica
GonzalezQuery 1: Opened Showing subject
was
re-consented
using the most
up to date ICFs,
however, source
pdf provided,
"Pfizer Peds
Consent", is
actually a copy
of the Medical
History log and
ConMed Log.
Please provide
copy of
consents for
review.
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496189
Page 129 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-05-2021
16:54:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496190
Page 130 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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-05-2021
16:58:07ACV0PF
EINFP60Data Entry:
FEVERInitial Entry
090177e19891a03c\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-2022-5812-0496191
Page 131 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00)
Central 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-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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
090177e19891a03c\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-2022-5812-0496192
Page 132 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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
090177e19891a03c\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-2022-5812-0496193
Page 133 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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
090177e19891a03c\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-2022-5812-0496194
Page 134 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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
090177e19891a03c\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-2022-5812-0496195
Page 135 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central 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
090177e19891a03c\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-2022-5812-0496196
Page 136 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAINInitial Entry
090177e19891a03c\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-2022-5812-0496197
Page 137 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NO
2.g Symptom:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WORInitial Entry
090177e19891a03c\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-2022-5812-0496198
Page 138 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)SENED
JOINT
PAIN
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.h Symptom:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JO
INT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496199
Page 139 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-05-2021 16:58:07
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::RE
DN
ES
S
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496200
Page 140 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subj
ect Diary was compl
eted?:NOInitial Entry
090177e19891a03c\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-2022-5812-0496201
Page 141 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TEInitial Entry
090177e19891a03c\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-2022-5812-0496202
Page 142 of 216
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection sit
e reactions presen
t on the last day t
he Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SIT
EInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-05-2021
16:58:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496203
Page 143 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-05-2021
16:55:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021Initial Entry
2.a
Date Location User Value Reason
Jan-05-2021
16:55:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identif
ier::1
Temperature: 97.0
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-05-2021
16:55:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
090177e19891a03c\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-2022-5812-0496204
Page 144 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Temperature:
Date Location User Value Reason
Jan-05-2021
16:55:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
97.0Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-05-2021
16:55:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-05-2021
16:55:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03c\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-2022-5812-0496205
Page 145 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-05-2021 16:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-05-2021 16:56:05
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021
04:36:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-05-2021
16:56:05
(UTC-06:00)
Central 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496206
Page 146 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-05-2021
16:56:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/4/2021Initial Entry
5.a
Date Location User Value Reason
Jan-06-2021
04:36:25
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8HDNInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-06-2021
04:36:25
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8HDNInitial Entry
090177e19891a03c\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-2022-5812-0496207
Page 147 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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-05-2021
16:57:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-05-2021 16:57:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-05-2021 16:57:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-05-2021
16:57:12
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021 16:37Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496208
Page 148 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Anatomical Location:
Date Location User Value Reason
Jan-05-2021 16:57:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-05-2021
16:57:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-05-2021 16:57:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-05-2021 16:57:12
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496209
Page 149 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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-05-2021
16:57:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496210
Page 150 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-07-2021
12:45:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/6/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496211
Page 151 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-07-2021
12:47:49
(UTC-06:00)
Central 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
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
RInitial Entry
090177e19891a03c\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-2022-5812-0496212
Page 152 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:
2.a Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-07-2021
12:47:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 Data Entry:
Symptom:: FATIGU
EInitial Entry
090177e19891a03c\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-2022-5812-0496213
Page 153 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada) Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:YES
Ongoin
g?
NO
Sto
p D
ate:
Ja
n/
9/
20
21
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496214
Page 154 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central 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
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:
Jan/9/2021Initial Entry
2.c
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HEADA
CHEInitial Entry
090177e19891a03c\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-2022-5812-0496215
Page 155 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:YES
Ongoin
g?
NO
Sto
p D
ate:
Ja
n/
9/
20
21
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496216
Page 156 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central 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
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:
Jan/9/2021Initial Entry
2.d
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: CHILLSInitial Entry
090177e19891a03c\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-2022-5812-0496217
Page 157 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:YES
Ongoin
g?
NO
Sto
p D
ate:
Ja
n/
9/
20
21
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496218
Page 158 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central 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
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:
Jan/9/2021Initial Entry
2.e
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
GInitial Entry
090177e19891a03c\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-2022-5812-0496219
Page 159 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NO
2.e Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central 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
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RHInitial Entry
090177e19891a03c\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-2022-5812-0496220
Page 160 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada) EA
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:NO
2.f Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WORInitial Entry
090177e19891a03c\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-2022-5812-0496221
Page 161 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)SENED
MUSCL
E PAIN
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NO
2.g Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496222
Page 162 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JO
INT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03c\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-2022-5812-0496223
Page 163 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3. Injection Site Location:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::RE
DN
ES
S
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496224
Page 164 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a Injection Site Reaction:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subj
ect Diary was compl
eted?:NOInitial Entry
090177e19891a03c\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-2022-5812-0496225
Page 165 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TEInitial Entry
090177e19891a03c\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-2022-5812-0496226
Page 166 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection sit
e reactions presen
t on the last day t
he Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SIT
EInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-07-2021
12:47:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496227
Page 167 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021
07:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021
07:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021
07:30:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-08-2021
07:30:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496228
Page 168 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-08-2021
07:30:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/6/2021Initial Entry
5.a
Date Location User Value Reason
Feb-08-2021
07:30:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSGV4NInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-08-2021
07:30:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BSGV4NInitial Entry
5.b
Date Location User Value Reason
Feb-08-2021
07:47:55ACV0PF
EINFP60Data Entry: Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496229
Page 169 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US &
Canada)00 Sample ID: BR5J35
5.b Sample ID
Date Location User Value Reason
Feb-08-2021
07:47:55
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BR5J35Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496230
Page 170 of 216
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Feb-07-2021
12:48:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/6/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-07-2021
12:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Feb-07-2021
12:48:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496231
Page 171 of 216
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
May-13-2021
16:01:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Fredrick
OkworiData Entry:
May/10/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496232
Page 172 of 216
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
May-13-2021
16:02:40
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
May-13-2021
16:02:23
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP visit.
Please complete
this date.
May-13-2021
16:02:23
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Fredrick
OkworiData Entry:
Participant is willing to retu
rn for Vaccination 3
Participant is:
eligible per local/nationa
l recommendations and c
onfirmed to have receive
d only placebo at Vaccin
ation 1/2Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496233
Page 173 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 James
McMullenForm Created
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496234
Page 174 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 James
McMullenForm Created
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496235
Page 175 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-21-2021
06:33:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 3: Closed Response satisfies
query
Feb-19-2021
11:11:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.DiscrepPFETMS
OracleQuery 2: Closed Discrepancy has
been closed.
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2022-5812-0496236
Page 176 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
ancy
Feb-19-2021
09:36:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Closed Response satisfies
query
Feb-19-2021
08:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 3: Answered Changed
Information
Feb-19-2021
08:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Answered Changed
Information
Feb-19-2021
08:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Acute appendicitisChanged
Information
Feb-19-2021
03:43:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 3: Opened SAE RECON:
AER#2021104203,
event term
recorded as 'Acute
appendicitis with
localized
peritonitis, without
perforation or
gangrene '. Please
consider to split
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496237
Page 177 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
the term an record
as separate entries
to facilitate coding
and match SDB.
Feb-15-2021
12:41:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy PFETMS
OracleQuery 2: Opened Multiple concepts
in the term
ACUTE
APPENDICITIS
WITH
LOCALIZED
PERITONITIS,
WITHOUT
PERFORATION
OR GANGRENE.
Split the term into
ACUTE
APPENDICITIS
and LOCALIZED
PERITONITIS,
WITHOUT
PERFORATION
OR GANGRENE
and submit
separately. Thank
you.
Feb-15-2021
11:13:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Acute appendicitis with
localized peritonitis, wit
hout perforation or gang
reneNew Information
Feb-15-2021
10:22:41ACV0PF
EINFP60James
McMullenQuery 1: Answered Per pathology
report, no necrosis,
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496238
Page 178 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00)
Central Time (US
& Canada)00 gangrene or
perforation
occurred
Feb-13-2021
07:23:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Reissued:Open
edIt is intended to
confirm if
necrosis, gangrene
or any perforation
occurred. Thanks
Feb-05-2021
13:48:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Please clarify the
desired
information from
pathology report.
Final diagnosis
from pathology
report is Acute
appendicitis
Feb-03-2021
16:32:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Giselle Castillo Query 1: Opened CLINICAL_ Pls
provide, if
available, results
from pathology
report. Thank you.
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Acute appendicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496239
Page 179 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jan/22/2021 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NO
End Date Time:
Jan/23/2021 00:01Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496240
Page 180 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-05-2021
08:23:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate For AE Acute
appendicitis :
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event re
quire or prolong hospital
ization?Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496241
Page 181 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
YES
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importa
nt serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496242
Page 182 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is d
ue to:
OTHER
If Other, specify:
Acute appendicitisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496243
Page 183 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-01-2021
14:58:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-05-2021
08:23:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
2021104203Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496244
Page 184 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
localized peritonitis, witho
ut perforation or gangreneInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496245
Page 185 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jan/22/2021 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NO
End Date Time:
Jan/23/2021 00:01Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496246
Page 186 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-21-2021
06:33:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate For AE
localized
peritonitis,
without
perforation or
gangrene :
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NOInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496247
Page 187 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Did this serious event re
quire or prolong hospital
ization?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importa
nt serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496248
Page 188 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is d
ue to:
OTHER
If Other, specify:
Acute appendicitisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496249
Page 189 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-19-2021
08:50:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-21-2021
06:33:28ACV0PF
EINFP60Data Entry:
2021104203Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496250
Page 190 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US & Canada)00
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496251
Page 191 of 216
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
May-13-2021
16:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Fredrick
OkworiData Entry:
May/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
May-13-2021
16:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Fredrick
OkworiData Entry:
ASSESS ELIGIBILITY FO
R ADDITIONAL VACCIN
ATIONInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496252
Page 192 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
May-19-2021
02:45:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
May-17-2021
21:25:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data per
query
May-17-2021
06:00:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened DM: Kindly review
and complete
‘Vaccination,
Immunogenicity
Nasal Swab and
Inclusion/Exclusion
Criteria form' at
this visit. Thank
you.
May-15-2021
04:15:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
May/14/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496253
Page 193 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
May-15-2021
04:16:17
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
May/14/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496254
Page 194 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
May-15-2021
04:16:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
May/14/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
May-15-2021
04:16:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
May-15-2021
04:16:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496255
Page 195 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
May-17-2021
21:23:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
May-17-2021
21:23:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
May-18-2021
08:16:47
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
May-17-2021
21:23:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496256
Page 196 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
May-17-2021
21:23:38
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
May/14/2021Initial Entry
5.a
Date Location User Value Reason
May-18-2021
08:16:47
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BV1K43Initial Entry
5.a Sample ID
Date Location User Value Reason
May-18-2021
08:16:47
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BV1K43Initial Entry
5.b
Date Location User Value Reason
May-18-2021
08:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BV1K44Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496257
Page 197 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
May-18-2021
08:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BV1K44Initial Entry
5.c
Date Location User Value Reason
May-18-2021
08:30:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSC42GInitial Entry
5.c Sample ID
Date Location User Value Reason
May-18-2021
08:30:52
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BSC42GInitial Entry
5.d
Date Location User Value Reason
May-18-2021
08:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSC42VInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496258
Page 198 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.d Sample ID
Date Location User Value Reason
May-18-2021
08:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BSC42VInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496259
Page 199 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
May-17-2021
21:23:57
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
May-17-2021
21:23:57
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
May-18-2021
08:25:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
May-17-2021
21:23:57
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496260
Page 200 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
May-17-2021
21:23:57
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
May/14/2021Initial Entry
5.a
Date Location User Value Reason
May-18-2021
08:25:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BV1K3DInitial Entry
5.a Sample ID
Date Location User Value Reason
May-18-2021
08:25:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BV1K3DInitial Entry
090177e19891a03c\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-2022-5812-0496261
Page 201 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) CentralACV0PF
EINFP60
00 Data Entry:
May/14/2021 14:36Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496262
Page 202 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
5. Anatomical Location:
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
30.0Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496263
Page 203 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
9. Unit:
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
May-17-2021
21:24:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496264
Page 204 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jun-07-2021
15:24:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jun/3/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496265
Page 205 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jun-07-2021 17:00:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jun-07-2021 17:00:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jun-07-2021
17:00:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jun-07-2021
17:00:30
(UTC-06:00)
Central 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
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496266
Page 206 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jun-07-2021
17:00:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YES
Date of Collection:
Jun/3/2021Initial Entry
5.a
Date Location User Value Reason
Jun-07-2021
17:00:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Sample ID: BV1K5HInitial Entry
5.a Sample ID
Date Location User Value Reason
Jun-07-2021
17:00:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
BV1K5HInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496267
Page 207 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Jun-07-2021
15:25:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jun-07-2021 15:25:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jun-07-2021 15:25:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jun-07-2021
15:25:46
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 James
McMullenData Entry:
Jun/3/2021 10:32Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496268
Page 208 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Anatomical Location:
Date Location User Value Reason
Jun-07-2021 15:25:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jun-07-2021
15:25:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jun-07-2021 15:25:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jun-07-2021 15:25:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
30.0Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496269
Page 209 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
9. Unit:
Date Location User Value Reason
Jun-07-2021 15:25:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jun-07-2021 15:25:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jun-07-2021
15:25:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496270
Page 210 of 216
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-23-2021
03:24:16
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Clo
seddata updated
Jul-22-2021
00:42:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: An
sweredOriginal value is correct
Jul-20-2021
04:59:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Op
enedDM : Visit 103 Date is entered but
Disposition Treatment at
FURTHER_VACCINATION_EOT
visit is missing. Please check and
update else clarify.
Jul-13-2021
11:03:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jul/7/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496271
Page 211 of 216
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Jul-13-2021 11:03:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Jul-13-2021
11:03:59
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Contact:
Jul/7/2021Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496272
Page 212 of 216
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 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
Jul-22-2021
00:41:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jul/7/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jul-22-2021 00:41:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Jul-22-2021
00:41:46
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496273
Page 213 of 216
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-07-2021
12:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Dec-13-2020
14:25:50
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Dec-13-2020
14:17:57
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jun-10-2021
03:14:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Query 3: Closed Visit was updated
Jun-09-2021
14:37:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 James
McMullenQuery 3: Answere
dVisit entered
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496274
Page 214 of 216
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jun-04-2021
07:27:27
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Balaji Prabu R Query 3: Opened Vaccination 4 is reported in
IRT, however,
V102_VAX4 is not
completed. Please review
and enter all CRF in the
vaccination visit or explain
otherwise.
Feb-15-2021
14:02:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Query 2: Closed Response satisfies query
Feb-15-2021
11:12:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 James
McMullenQuery 2: Answere
dAE CRF updated
Feb-15-2021
05:33:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Query 2: Opened SAE
RECON:AER#2021104203
localized peritonitis
without perforation or
gangrene(onset
date:22jAN2021)was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form
Feb-15-2021
05:32:43ACV0PF
EINFP60Query 1: Closed UPDATE QUERY TEXT
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496275
Page 215 of 216
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00)
Central Time
(US & Canada)00
Feb-15-2021
05:32:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Opened SAE
RECON:AER#2021104203
cal peritonitis (onset
date:22jAN2021)was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Feb-07-2021
12:48:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Feb/6/2021Initial Entry
Dec-13-2020
14:25:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Dec/12/2020Initial Entry
Dec-13-2020
14:17:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Dec/12/2020Initial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0496276
Page 216 of 216
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471281 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Mar-16-2021
16:24:10
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Click Here to EnableInitial Entry
090177e19891a03c\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496277