125742 45 S211 M5 c4591001 1147 11471327

Document text

Page 1 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496278
Page 2 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/5/2021
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496279
Page 3 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [11471327]
2.Birth Date: 2006
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:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0496280
Page 4 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496281
Page 5 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496282
Page 6 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/5/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496283
Page 7 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496284
Page 8 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496285
Page 9 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/5/2021
2.Weight: [167.2]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [27.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496286
Page 10 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/5/2021
2.Randomization Number: [25570]
3.Randomization Group: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496287
Page 11 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8HFV]
5.bSample ID [BP8HFW]
5.cSample ID [BSGV0P]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496288
Page 12 of 223
***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: 11471327 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/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8HFG]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496289
Page 13 of 223
***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: 11471327 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/5/2021 17:10
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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496290
Page 14 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496291
Page 15 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496292
Page 16 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496293
Page 17 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496294
Page 18 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT Comments
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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496295
Page 19 of 223
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/27/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496296
Page 20 of 223
***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: 11471327 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/27/2021
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 [BR5J0P]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496297
Page 21 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was
ObservedNot Applicable Comments
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496298
Page 22 of 223
***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: 11471327 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?Not Applicable Comments
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496299
Page 23 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496300
Page 24 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
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?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496301
Page 25 of 223
***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: 11471327 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?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496302
Page 26 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?Not Applicable Comments
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496303
Page 27 of 223
***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: 11471327 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/25/2021
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 [BR7X56]
5.bSample ID [BRZXLD]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496304
Page 28 of 223
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/28/2021
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496305
Page 29 of 223
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11471327 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:
Jul/28/2021
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 [BS2D9K]
5.bSample ID [BRND2G]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496306
Page 30 of 223
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496307
Page 31 of 223
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496308
Page 32 of 223
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496309
Page 33 of 223
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496310
Page 34 of 223
***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: 11471327 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:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496311
Page 35 of 223
***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: 11471327 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: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496312
Page 36 of 223
***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: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496313
Page 37 of 223
***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: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496314
Page 38 of 223
***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: 11471327 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?
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496315
Page 39 of 223
***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: 11471327 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:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496316
Page 40 of 223
***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: 11471327 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:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496317
Page 41 of 223
***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: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496318
Page 42 of 223
***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: 11471327 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:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496319
Page 43 of 223
***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: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496320
Page 44 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jan/06/2021Form: 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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496321
Page 45 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jan/06/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496322
Page 46 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jan/06/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 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:
Jan/6/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496323
Page 47 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496324
Page 48 of 223
***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: 11471327 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:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496325
Page 49 of 223
***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: 11471327 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?
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496326
Page 50 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496327
Page 51 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496328
Page 52 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496329
Page 53 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496330
Page 54 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496331
Page 55 of 223
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 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 [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496332
Page 56 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jan/8/2021
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496333
Page 57 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/6/2021
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496334
Page 58 of 223
***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: 11471327 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496335
Page 59 of 223
***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: 11471327 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: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496336
Page 60 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Fever (10
4.7) Jan/6/2021
19:30 NO
End Date Time:
Jan/8/2021 UNK:UN
K
 Repeating
Pages
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496337
Page 61 of 223
***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: 11471327 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)[Fever (104.7)]
4.Start Date Time: Jan/6/2021 19:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/8/2021 UNK:UNK
6.Toxicity Grade: 4
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496338
Page 62 of 223
***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: 11471327 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:DRUG WITHDRAWN
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496339
Page 63 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496340
Page 64 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496341
Page 65 of 223
***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: 11471327 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[ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496342
Page 66 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned Identifie
rCategory for
MedicationConcomitant Medi
cations Pre-specifie
dName of Medi
cationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  BNT162b2 Do
se #1 IM/once May/7/
2021 Repeating
Pages
 2.2  VACCINATI
ONS NO  BNT162b2 Do
se #2 IM/once Jun/4/
2021 Repeating
Pages
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496343
Page 67 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[BNT162b2 Dose #1 IM/once]
5.Date: May/7/2021
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496344
Page 68 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[BNT162b2 Dose #2 IM/once]
5.Date: Jun/4/2021
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496345
Page 69 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496346
Page 70 of 223
***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: 11471327 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?
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496347
Page 71 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496348
Page 72 of 223
***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: 11471327 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?
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496349
Page 73 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496350
Page 74 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496351
Page 75 of 223
***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496352
Page 76 of 223
***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 13-Apr-2021 01:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496353
Page 77 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/13/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496354
Page 78 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496355
Page 79 of 223
***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: 11471327 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: [ ]
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496356
Page 80 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/8/2021
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496357
Page 81 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496358
Page 82 of 223
***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: 11471327 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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496359
Page 83 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-06-2021 16:41:22 (UTC-06:00)
Central Time (US & Canada)not applicable
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496360
Page 84 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-06-2021 16:42:20 (UTC-06:00)
Central Time (US & Canada)not applicable
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496361
Page 85 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Mar-02-2021 14:43:57 (UTC-06:00)
Central Time (US & Canada)James
McMullen
4Jan-28-2021 00:20:22 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496362
Page 86 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496363
Page 87 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496364
Page 88 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496365
Page 89 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496366
Page 90 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496367
Page 91 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496368
Page 92 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496369
Page 93 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496370
Page 94 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496371
Page 95 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496372
Page 96 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
10Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496373
Page 97 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
11Jan-28-2021 00:17:40 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496374
Page 98 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMar-01-2021 12:22:25
(UTC-06:00) Central Time (US &
Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496375
Page 99 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Mar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496376
Page 100 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.aMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496377
Page 101 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.bMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496378
Page 102 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.cMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496379
Page 103 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.dMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496380
Page 104 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.eMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496381
Page 105 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.fMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496382
Page 106 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.gMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496383
Page 107 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2.hMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496384
Page 108 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Mar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496385
Page 109 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Mar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496386
Page 110 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5.aMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496387
Page 111 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5.bMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496388
Page 112 of 223
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - Comments
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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5.cMar-01-2021 12:22:25 (UTC-06:00)
Central Time (US & Canada)James
McMullenSubject discontinued from study
treatment. Did not receive
Vaccination 2
Not Applicable
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496389
Page 113 of 223
***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: 11471327 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-14-2021 09:57:49 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Mar-18-2021 21:42:13 (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.
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496390
Page 114 of 223
***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: 11471327 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
Jan-06-2021
16:39:14
(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
Jan-06-2021
16:39:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496391
Page 115 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-06-2021
16:39:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Jan/5/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496392
Page 116 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Jan-06-2021 16:38:51
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
11471327Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jan-06-2021 16:35:30
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2006Enrollment Entry
3. Sex:
Date Location User Value Reason
Jan-06-2021
16:40:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jan-07-2021
08:21:02
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH
ORIGINInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0496393
Page 117 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Race: (Check X all that apply):
Date Location User Value Reason
Jan-07-2021
08:21:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
6. Racial Designation:
Date Location User Value Reason
Jan-27-2021
01:17:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Jan-26-2021
20:27:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 2: Closed Auto closed by
Validation Check:
VC_DM001_09
Jan-26-2021
13:49:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Answere
dChanged Information
Jan-26-2021
13:49:21ACV0PF
EINFP60auto query
(autoquery)Query 1: Answere
dChanged Information
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0496394
Page 118 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00)
Central Time (US
& Canada)00 
Jan-26-2021
13:49:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry: Changed Information
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 DMW6938178;Racial
Designation is
updated, however
Race is not ASIAN.
Please review and
update appropriately
or clarify.
Jan-21-2021
09:49:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 1: Opened DMW6938178;Racial
Designation is
updated, however
Race is not ASIAN.
Please review and
update appropriately
or clarify.
Jan-06-2021
16:40:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
OTHERInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496395
Page 119 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021
16:40:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/5/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496396
Page 120 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jan-06-2021
16:41:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/5/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-06-2021 16:41:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-06-2021
16:41:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496397
Page 121 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-06-2021
16:43:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496398
Page 122 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/5/2021Initial Entry
2. Weight:
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
167.2Initial Entry
3. Unit:
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e19891a03b\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-2022-5812-0496399
Page 123 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jan-06-2021 16:47:10
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
27.0Initial Entry
7.a
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identif
ier::1
Temperature: 98.5
Temperature
Unit:FInitial Entry
090177e19891a03b\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-2022-5812-0496400
Page 124 of 223
***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: 11471327 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
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
7.a Temperature Location:
090177e19891a03b\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-2022-5812-0496401
Page 125 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-06-2021
16:47:10
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496402
Page 126 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jan-06-2021
16:44:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/5/2021Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-06-2021
16:44:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
25570Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496403
Page 127 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021 16:45:34
(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-06-2021 16:45:34
(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
Jan-07-2021
05:22:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-06-2021
16:45:34
(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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496404
Page 128 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-06-2021
16:45:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/5/2021Initial Entry
5.a
Date Location User Value Reason
Jan-07-2021
05:22:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8HFVInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-07-2021
05:22:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8HFVInitial Entry
5.b
Date Location User Value Reason
Jan-07-2021
05:23:18
(UTC-06:00) Central
Time (US &ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8HFWInitial Entry
090177e19891a03b\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-2022-5812-0496405
Page 129 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5.b Sample ID
Date Location User Value Reason
Jan-07-2021
05:23:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8HFWInitial Entry
5.c
Date Location User Value Reason
Jan-07-2021
05:47:16
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSGV0PInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-07-2021
05:47:16
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BSGV0PInitial Entry
090177e19891a03b\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-2022-5812-0496406
Page 130 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-06-2021 16:46:00
(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
Jan-06-2021 16:46:00
(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-07-2021
06:10:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-06-2021
16:46:00
(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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496407
Page 131 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-06-2021
16:46:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/5/2021Initial Entry
5.a
Date Location User Value Reason
Jan-07-2021
06:10:03
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP8HFGInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-07-2021
06:10:03
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BP8HFGInitial Entry
090177e19891a03b\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-2022-5812-0496408
Page 132 of 223
***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: 11471327 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-06-2021
16:44:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-06-2021 16:44:18
(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-06-2021 16:44:18
(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-06-2021
16:44:18
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 Data Entry:
Jan/5/2021 17:10Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496409
Page 133 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Anatomical Location:
Date Location User Value Reason
Jan-06-2021 16:44:18
(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-06-2021
16:44:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-06-2021 16:44:18
(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-06-2021 16:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496410
Page 134 of 223
***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: 11471327 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-06-2021
16:44:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496411
Page 135 of 223
***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: 11471327 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
Jan-06-2021
16:44:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTED
FOR THIS SUBJECTInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496412
Page 136 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021
00:13:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/27/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496413
Page 137 of 223
***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: 11471327 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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03ACV0PF
EINFP60Data Entry:
FEVERInitial Entry
090177e19891a03b\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-2022-5812-0496414
Page 138 of 223
***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: 11471327 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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-28-2021
00:20:03
(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
090177e19891a03b\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-2022-5812-0496415
Page 139 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-28-2021
00:20:03
(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
090177e19891a03b\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-2022-5812-0496416
Page 140 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-28-2021
00:20:03
(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
090177e19891a03b\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-2022-5812-0496417
Page 141 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-28-2021
00:20:03
(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
090177e19891a03b\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-2022-5812-0496418
Page 142 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-28-2021
00:20:03
(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
090177e19891a03b\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-2022-5812-0496419
Page 143 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAINInitial Entry
090177e19891a03b\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-2022-5812-0496420
Page 144 of 223
***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: 11471327 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-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-28-2021
00:20:03
(UTC-06:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WORInitial Entry
090177e19891a03b\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-2022-5812-0496421
Page 145 of 223
***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: 11471327 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-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496422
Page 146 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-28-2021 00:20:03
(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
Mar-02-2021
23:12:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-02-2021
14:44:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Initial Entry
Mar-02-2021
14:44:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
LEFTInitial Entry
Mar-02-2021
14:43:57
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Initial Entry
Mar-02-2021
14:33:21
(UTC-06:00)ACV0PF
EINFP60
00 Query 1: Opened Subject received
Vax 1 so NOT
APPLICABLE
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496423
Page 147 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)is not an
acceptable
response for
INJECTION
SITE BODY
SIDE in this
CRF. Please
update
INJECTION
SITE BODY
SIDE in this
CRF (based on
Vax 1 injection
site laterality) as
data point is
required.
Jan-28-2021
00:20:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Jan-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::RE
DN
ES
SInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496424
Page 148 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-28-2021
00:20:03
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
INGInitial Entry
090177e19891a03b\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-2022-5812-0496425
Page 149 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada) Were injection site r
eactions present on t
he last day the Subj
ect Diary was compl
eted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-28-2021
00:20:03
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTIInitial Entry
090177e19891a03b\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-2022-5812-0496426
Page 150 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada) ON SI
TE
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-28-2021
00:20:03
(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-28-2021
00:20:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496427
Page 151 of 223
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-28-2021
00:14:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/27/2021Initial Entry
2.a
Date Location User Value Reason
Jan-28-2021
00:14:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identif
ier::1
Temperature: 98.6
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-28-2021
00:14:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
090177e19891a03b\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-2022-5812-0496428
Page 152 of 223
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Temperature:
Date Location User Value Reason
Jan-28-2021
00:14:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-28-2021
00:14:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-28-2021
00:14:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03b\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-2022-5812-0496429
Page 153 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 00:15:03
(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-28-2021 00:15:03
(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-28-2021
07:55:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-28-2021
03:12:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0496430
Page 154 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-28-2021
00:15:03
(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.
Jan-28-2021
00:15:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-28-2021
07:55:42
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5J0PInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-28-2021
07:55:42
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BR5J0PInitial Entry
090177e19891a03b\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-2022-5812-0496431
Page 155 of 223
***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: 11471327 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
Feb-01-2021
00:03:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Jan-29-2021
11:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answere
dsubject discontinued
Jan-29-2021
02:20:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 1: Opened DMW7042935;Temp
Delay is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
2. Treatment Name
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496432
Page 156 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-01-2021
05:06:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy DMW QUERY Query 1: Closed Confirmed As-Is
Jan-29-2021
11:27:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered Subject discontinued
Jan-29-2021
02:22:01
(UTC-06:00)
Central Time (USACV0PF
EINFP60
00.InFor
mAdapteDMW QUERY Query 1: Opened DMW7042957;Dose
Date is not expected
to be Unknown or
Not Applicable.
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0496433
Page 157 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) r.Discrep
ancy Please review and
update appropriately
or clarify
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
090177e19891a03b\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-2022-5812-0496434
Page 158 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)
8. Actual Dose:
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
9. Unit:
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
090177e19891a03b\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-2022-5812-0496435
Page 159 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-28-2021
00:17:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496436
Page 160 of 223
***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: 11471327 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-26-2021
17:21:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/25/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496437
Page 161 of 223
***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: 11471327 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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:20:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: FE
VE
RInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0496438
Page 162 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:Not
App
lica
ble
Mar-01-2021
12:20:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: FE
V
E
R
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
R
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496439
Page 163 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:20:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Mar-01-2021
12:22:25
(UTC-06:00)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: FATInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0496440
Page 164 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)IG
UE
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:Not
App
lica
ble
Mar-01-2021
12:20:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: FA
TI
G
UE
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
G
UE
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:N
OInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496441
Page 165 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:20:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496442
Page 166 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: HE
AD
AC
HE
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:Not
App
lica
bleInitial Entry
Mar-01-2021
12:21:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: HE
AD
AC
HE
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496443
Page 167 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:21:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496444
Page 168 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: CHI
LL
S
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:Not
App
lica
bleInitial Entry
Mar-01-2021
12:21:08
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: C
HI
LL
S
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:N
OInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496445
Page 169 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:21:08
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496446
Page 170 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: VO
MIT
ING
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:Not
App
lica
bleInitial Entry
Mar-01-2021
12:21:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: VO
MI
TIN
G
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496447
Page 171 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:21:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496448
Page 172 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: DI
AR
RH
EA
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:Not
App
lica
bleInitial Entry
Mar-01-2021
12:21:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: DI
AR
RH
EA
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496449
Page 173 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:21:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496450
Page 174 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: NEW O
R WOR
SENED
MUSC
LE PAI
N
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:Not Ap
plicableInitial Entry
Mar-01-2021
12:21:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: NEW O
R WOR
SENED
MUSC
LE PAI
N
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WORInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496451
Page 175 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)SENED
MUSC
LE PAI
N
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NO
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496452
Page 176 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:21:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496453
Page 177 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT P
AIN
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:Not Ap
plicableInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496454
Page 178 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
2.h
Date Location User Value Reason
Mar-01-2021
12:21:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT P
AIN
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT P
AINInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496455
Page 179 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NO
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496456
Page 180 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED J
OINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:21:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496457
Page 181 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Mar-01-2021
12:22:25
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:20:36
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry: Changed
Information
Feb-26-2021
17:23:22
(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
Mar-02-2021
05:04:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-01-2021
12:22:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Subject
discontinued
from study
treatment
Mar-01-2021
12:22:25ACV0PF
EINFP60James
McMullenData Entry:
Not ApplicableInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0496458
Page 182 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00)
Central Time (US &
Canada)00 
Mar-01-2021
02:26:57
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened DM: Please
complete this
item. Thank
you.
5.a
Date Location User Value Reason
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Injection Site Reac
tion::RE
DN
ESS
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:Not
App
lica
bleInitial Entry
Mar-01-2021
12:21:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Injection Site React
ion::RE
DN
ES
SChanged
Information
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496459
Page 183 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection site
reactions present o
n the last day the S
ubject Diary was co
mpleted?:
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site React
ion::RE
DN
ES
S
Were injection site
reactions present o
n the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25ACV0PF
EINFP60James
McMullenData Entry:
Not ApplicableInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496460
Page 184 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00)
Central Time (US &
Canada)00 
Mar-01-2021
12:21:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Injection Site Rea
ction::SW
ELL
ING
Were injection site
reactions present
on the last day the
Subject Diary was
completed?:Not
App
licab
leInitial Entry
Mar-01-2021
12:21:56
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 James
McMullenData Entry:
Injection Site Reac
tion::SW
ELChanged
Information
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496461
Page 185 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada) LIN
G
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::SW
EL
LIN
G
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496462
Page 186 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:21:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496463
Page 187 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Injection Site Re
action::PAIN
AT IN
JECTI
ON SI
TE
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:Not A
pplica
bleInitial Entry
Mar-01-2021
12:22:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Injection Site Re
action::PAIN
AT IN
JECTI
ON SI
TE
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Re
action::PAIN
AT IN
JECTI
ON SIInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496464
Page 188 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
TE
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:NO
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496465
Page 189 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-26-2021
17:23:22
(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
Mar-01-2021
12:22:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-01-2021
12:22:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Feb-26-2021
17:23:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496466
Page 190 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
07:59:30
(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-26-2021
07:59:30
(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-26-2021
08:00:08
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-26-2021
07:59:30
(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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496467
Page 191 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-26-2021
07:59:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
08:00:08
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR7X56Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
08:00:08
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BR7X56Initial Entry
5.b
Date Location User Value Reason
Feb-26-2021
08:28:35ACV0PF
EINFP60Data Entry: Initial Entry
090177e19891a03b\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-2022-5812-0496468
Page 192 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-06:00) Central
Time (US &
Canada)00  Sample ID: BRZXLD
5.b Sample ID
Date Location User Value Reason
Feb-26-2021
08:28:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRZXLDInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496469
Page 193 of 223
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-09-2021
14:13:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Aug-09-2021
12:51:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsQuery 1: Answered Changed data
per query
Aug-05-2021
15:18:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened Per source
documentation,
subject received
non study
vaccine on
07May2021 and
04Jun2021.
Please update
Concomitant
Vaccine Log.
Jul-28-2021
23:33:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jul/28/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496470
Page 194 of 223
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-28-2021 23:34:10
(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
Jul-28-2021 23:34:10
(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
Jul-29-2021
06:57:26
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jul-28-2021
23:34:10
(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
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496471
Page 195 of 223
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jul-28-2021
23:34:10
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jul/28/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Jul-29-2021
06:58:25
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry: Initial Entry
5.a
Date Location User Value Reason
Jul-29-2021
06:57:26
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry:
Sample ID: BS2D9KInitial Entry
5.a Sample ID
Date Location User Value Reason
Jul-29-2021
06:57:26
(UTC-06:00) CentralACV0PF
EINFP60
00 Katherine
DownsData Entry:
BS2D9KInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496472
Page 196 of 223
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US &
Canada)
5.b
Date Location User Value Reason
Jul-29-2021
06:58:32
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry:
Sample ID: BRND2GInitial Entry
5.b Sample ID
Date Location User Value Reason
Jul-29-2021
06:58:32
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry:
BRND2GInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496473
Page 197 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jan/06/2021Form: 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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-07-2021
10:30:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jan/6/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496474
Page 198 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jan/06/2021Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Assessments
Date Location User Value Reason
Jan-07-2021
10:31:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-07-2021
10:30:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Jan-07-2021
10:30:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
CONTACT OUTCOMEInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496475
Page 199 of 223
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jan/06/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Jan-07-2021 10:30:46
(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
Jan-07-2021
10:31:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-07-2021
10:31:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YES
Date of Contact:
Jan/6/2021
Contact Outcome:
VISIT NOT REQUIRE
D, INVESTIGATOR D
ECISIONChanged
Information
Jan-07-2021
10:30:46
(UTC-06:00)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Response to
"Date of
Contact" is
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496476
Page 200 of 223
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Jan/06/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Central Time (US &
Canada)missing.
Jan-07-2021
10:30:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
YES
Contact Outcome:
VISIT NOT REQUIRE
D, INVESTIGATOR D
ECISIONInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496477
Page 201 of 223
***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: 11471327 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
Mar-03-2021
11:18:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jan/8/2021Changed
Information
Jan-28-2021
08:47:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Jan/9/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-28-2021 08:47:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Mar-04-2021
09:18:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Hayley Wyper Query 1: Closed Response
satisfies query
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496478
Page 202 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-03-2021
15:56:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Closed Close Auto
Query
Mar-03-2021
15:55:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Opened Response to
"Status" is
ADVERSE
EVENT but
"Specify Status"
is Provided.
Mar-03-2021
15:55:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Changed
Information
Mar-03-2021
15:55:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
ADVERSE EVENTChanged
Information
Mar-03-2021
15:25:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Hayley Wyper Query 1: Reissued:Opene
dCLINQUERY:
Comment and
AE log reports
'fever' as event
leading to
treatment
discontinuation.
Please match
status selection
to this event
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496479
Page 203 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(status
ADVERSE
EVENT)
Mar-03-2021
11:19:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Reason updated.
Please unfreeze
DOV for visit 2
Mar-03-2021
00:59:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened CLINQUERY:
EOT date and
status should
match to reason
why Vax 2 was
not given. Please
review and
update. Current
entry is
inadequate for
reporting end of
treatment
Mar-02-2021
07:55:21
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Hayley Wyper Query 1: Candidate CLINQUERY:
EOT date and
status should
match to reason
why Vax 2 was
not given. Please
review and
update. Current
entry is
inadequate for
reporting end of
treatment
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2022-5812-0496480
Page 204 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-28-2021
08:47:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
OTHERInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-03-2021
15:56:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry: Changed
Information
Mar-03-2021
15:26:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Hayley Wyper Query 1: Closed Response
satisfies query
Mar-03-2021
12:57:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered AE leading to
treatment
discontinuation
captured in AE
log
Mar-03-2021
12:33:55
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Hayley Wyper Query 1: Opened CLINQUERY:
Fever is reported
leading to
treatment
discontinuation.
However, an AE
entry has not
been reported.
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496481
Page 205 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Please review -
any event
leading to
discontinuation
should be
reported even if
captured in
ediary
Mar-03-2021
11:19:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Treatment discontinued d
ue to fever of 104.7Changed
Information
Mar-03-2021
11:16:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Treatment discontinued d
ue to COVID IllnessChanged
Information
Jan-28-2021
08:47:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Treatment discontinuedInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496482
Page 206 of 223
***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: 11471327 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-14-2021
09:57:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Fredrick
OkworiData Entry:
May/6/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496483
Page 207 of 223
***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: 11471327 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-14-2021
09:58:40
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
May-14-2021
09:58:16
(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-14-2021
09:58:16
(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 and NOT confir
med to have received on
ly placebo at Vaccinatio
n 1/2Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496484
Page 208 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Date Location User Value Reason
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 James
McMullenForm Created
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496485
Page 209 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021
12:56:50
(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
Mar-03-2021
12:56:50
(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
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
Fever (104.7)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-03-2021 ACV0PF James Data Entry: Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496486
Page 210 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12:56:50
(UTC-06:00)
Central Time (US &
Canada)EINFP60
00 McMullen Jan/6/2021 19:30
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NO
End Date Time:
Jan/8/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021
13:35:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-11-2021
07:41:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenQuery 1: Answered Per Table 3, a
fever >104.0F is
a grade 4.
Mar-11-2021
07:21:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened GPD Clin:
Fever alone
may not
typically be
considered life
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496487
Page 211 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
threatening AE.
Please review
and confirm if
toxicity grade
assignment
appropriate and
provide
rationale in
query response.
Mar-03-2021
12:56:50
(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).
Date Location User Value Reason
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496488
Page 212 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Mar-03-2021
12:56:50
(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
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &ACV0PF
EINFP60
00 James
McMullenData Entry:
YESInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496489
Page 213 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021
12:56:50
(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
Mar-03-2021
12:56:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PF
EINFP60
00 James
McMullenData Entry:
NOInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496490
Page 214 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Date Location User Value Reason
Aug-09-2021
12:50:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Katherine
DownsForm Created
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496491
Page 215 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Date Location User Value Reason
Aug-09-2021
12:51:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Katherine
DownsForm Created
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496492
Page 216 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Aug-09-2021
12:50:41
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Aug-09-2021
12:50:41
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Aug-09-2021
12:50:41
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic
name is unknown, enter the full trade or proprietary name. Include clarifying information in
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496493
Page 217 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Aug-09-2021
12:50:41
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry:
BNT162b2 Dose #1 IM/onc
eInitial Entry
5. Date:
Date Location User Value Reason
Aug-09-2021
12:50:41
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry:
May/7/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496494
Page 218 of 223
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Aug-09-2021
12:51:07
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Aug-09-2021
12:51:07
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Aug-09-2021
12:51:07
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic
name is unknown, enter the full trade or proprietary name. Include clarifying information in
the Medication text (e.g., Ingredient(s), route, use, formulation).
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496495
Page 219 of 223
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Aug-09-2021
12:51:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry:
BNT162b2 Dose #2 IM/onc
eInitial Entry
5. Date:
Date Location User Value Reason
Aug-09-2021
12:51:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PF
EINFP60
00 Katherine
DownsData Entry:
Jun/4/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496496
Page 220 of 223
***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: 11471327 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-14-2021
09:58:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Fredrick
OkworiData Entry:
May/13/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
May-14-2021
09:58:40
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Fredrick
OkworiData Entry:
ASSESS ELIGIBILITY FO
R ADDITIONAL VACCIN
ATIONInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0496497
Page 221 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-03-2021
15:55:54
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged
Information
Jan-28-2021 08:47:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Jan-06-2021 16:44:58
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Jan-06-2021 16:41:49
(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
Mar-03-2021
15:55:54
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Jan/8/2021Changed
Information
Mar-03-2021
11:18:35
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Jan/8/2021Changed
Information
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496498
Page 222 of 223
***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: 11471327 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-28-2021 08:47:59
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Jan/9/2021Initial Entry
Jan-06-2021 16:44:58
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Jan/5/2021Initial Entry
Jan-06-2021 16:41:49
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Jan/5/2021Initial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496499
Page 223 of 223
***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: 11471327 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
16:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Click Here to EnableInitial Entry
090177e19891a03b\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0496500