125742 S1 M5 CRF c4591001 1147 11471239

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

267

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Page 1 of 267
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811448
Page 2 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811449
Page 3 of 267
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11471239]
2.Birth Date: /1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811450
Page 4 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811451
Page 5 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811452
Page 6 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811453
Page 7 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Sep/13/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Sep/14/2012
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[mennorrhagia]
Start Date: Apr/18/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: Dec/3/2012
Ongoing: YES
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811454
Page 8 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[IRREGULAR MENSTRUAL CYCLE]
Start Date: Apr/18/2019
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[menopause]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811455
Page 9 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [127.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [21.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811456
Page 10 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811457
Page 11 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [256095]
3.Randomization Group: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811458
Page 12 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3FW]
5.bSample ID [BPY3FX]
5.cSample ID [BPY3FV]
5.dSample ID [BPLF56]
5.eSample ID [BPLF4S]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811459
Page 13 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3G3]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811460
Page 14 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/10/2020 12:46
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
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811461
Page 15 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811462
Page 16 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811463
Page 17 of 267
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811464
Page 18 of 267
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811465
Page 19 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3PY]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811466
Page 20 of 267
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/30/2020 11:57
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
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811467
Page 21 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811468
Page 22 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMNV0M]
5.bSample ID [BMNV0C]
5.cSample ID [BR7XLB]
5.dSample ID [BR7XLC]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811469
Page 23 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811470
Page 24 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/16/2020
2.Date of First Symptom Started: Nov/12/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/16/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811471
Page 25 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Fatigue]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811472
Page 26 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/13/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811473
Page 27 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/13/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811474
Page 28 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV14381]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811475
Page 29 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Site did not collect swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811476
Page 30 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811477
Page 31 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811478
Page 32 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811479
Page 33 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811480
Page 34 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811481
Page 35 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811482
Page 36 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811483
Page 37 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811484
Page 38 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811485
Page 39 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811486
Page 40 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811487
Page 41 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811488
Page 42 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811489
Page 43 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811490
Page 44 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811491
Page 45 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
 1.      Repeating Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811492
Page 46 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811493
Page 47 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811494
Page 48 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811495
Page 49 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811496
Page 50 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811497
Page 51 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811498
Page 52 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSGTWD]
5.bSample ID [BSGTWV]
5.cSample ID [BP8H5Z]
5.dSample ID [BP8H60]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811499
Page 53 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811500
Page 54 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811501
Page 55 of 267
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811502
Page 56 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811503
Page 57 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811504
Page 58 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811505
Page 59 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  Ovarian Mass  Sep/21/2020
UNK:UNK YES  Repeating
Pages
 2. ADVERSE
EVENT 2  Increased HDL (9
5) Sep/18/2020
UNK:UNK YES  Repeating
Pages
 3. ADVERSE
EVENT 3  Left Lower Quadr
ant Pain Sep/25/2020
UNK:UNK YES  Repeating
Pages
 4. ADVERSE
EVENT 4  Trace Ketones (Ur
inalysis) Sep/24/2020
UNK:UNK YES  Repeating
Pages
 5. ADVERSE
EVENT 5  Trace Leukocytes
in Urinalysis Sep/24/2020
UNK:UNK YES  Repeating
Pages
 6. ADVERSE
EVENT 6  Decreased Sodium
(131) Sep/24/2020
UNK:UNK YES  Repeating
Pages
 7. ADVERSE
EVENT 7  Decreased Chlorid
e (94) Sep/24/2020
UNK:UNK YES  Repeating
Pages
 8. DELETED ADVERSE
EVENT 8  Ovarian Mass  Sep/21/2020
UNK:UNK YES  Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811506
Page 60 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[Ovarian Mass]
4.Start Date Time: Sep/21/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811507
Page 61 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Ovarian mass of unknown origin]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020403508]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811508
Page 62 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Increased HDL (95)]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811509
Page 63 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to the study treatment]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811510
Page 64 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left Lower Quadrant Pain]
4.Start Date Time: Sep/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811511
Page 65 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to the study treatment]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811512
Page 66 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Trace Ketones (Urinalysis)]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811513
Page 67 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to study treatment]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811514
Page 68 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Trace Leukocytes in Urinalysis]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811515
Page 69 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to the study treatment]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811516
Page 70 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Decreased Sodium (131)]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811517
Page 71 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to the study]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811518
Page 72 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Decreased Chloride (94)]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811519
Page 73 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to study treatment]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811520
Page 74 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Ovarian Mass ]
4.Start Date Time: Sep/21/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811521
Page 75 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not related to the study ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811522
Page 76 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811523
Page 77 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811524
Page 78 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811525
Page 79 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811526
Page 80 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811527
Page 81 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811528
Page 82 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811529
Page 83 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811530
Page 84 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811531
Page 85 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811532
Page 86 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811533
Page 87 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811534
Page 88 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811535
Page 89 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811536
Page 90 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811537
Page 91 of 267
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811538
Page 92 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811539
Page 93 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811540
Page 94 of 267
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811541
Page 95 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811542
Page 96 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811543
Page 97 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811544
Page 98 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/26/2021
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811545
Page 99 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811546
Page 100 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811547
Page 101 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811548
Page 102 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BRZXLZ]
5.bSample ID [BRZXMC]
5.cSample ID [BR7X6B]
5.dSample ID [BR7X6C]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811549
Page 103 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BR7X3L]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811550
Page 104 of 267
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/26/2021 11:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811551
Page 105 of 267
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811552
Page 106 of 267
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811553
Page 107 of 267
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811554
Page 108 of 267
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811555
Page 109 of 267
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811556
Page 110 of 267
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811557
Page 111 of 267
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811558
Page 112 of 267
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811559
Page 113 of 267
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811560
Page 114 of 267
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811561
Page 115 of 267
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811562
Page 116 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/28/2020
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811563
Page 117 of 267
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811564
Page 118 of 267
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811565
Page 119 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-10-2020 13:25:55 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay all inclusion criteria met and no exclusion
criteria met
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811566
Page 120 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811567
Page 121 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Sep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811568
Page 122 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Sep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811569
Page 123 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Sep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811570
Page 124 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Sep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811571
Page 125 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Sep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811572
Page 126 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811573
Page 127 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811574
Page 128 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-10-2020 13:30:48 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of childbearing potential
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811575
Page 129 of 267
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Oct-01-2020 09:14:31 (UTC-06:00) Central
Time (US & Canada)menopause 2009
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811576
Page 130 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-28-2021 01:49:31 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811577
Page 131 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811578
Page 132 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811579
Page 133 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811580
Page 134 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811581
Page 135 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811582
Page 136 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Feb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811583
Page 137 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811584
Page 138 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811585
Page 139 of 267
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-28-2021 01:51:39 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811586
Page 140 of 267
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-19-2021 12:25:04 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Jan-26-2021 06:23:33 (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.
Fredrick
Okwori N/A Dec-15-2020 12:02:35 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Nov-17-2020 20:36:21 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811587
Page 141 of 267
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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.
James
McMullen N/A Nov-17-2020 19:45:36 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Nov-16-2020 15:24:28 (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.
James
McMullen N/A Nov-16-2020 10:34:27 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Nov-09-2020 14:52:10 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811588
Page 142 of 267
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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.
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811589
Page 143 of 267
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020 13:24:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-10-2020 13:24:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811590
Page 144 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020 13:24:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
OBTAINED
Date Written Consent Obta
ined
Sep/10/2020Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811591
Page 145 of 267
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-10-2020 13:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11471239Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020 13:23:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-23-2020
05:29:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed SDB updated. issue
resolved
Oct-21-2020
22:55:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:C
andidateSAE RECON: To check
SAE listing if gender will
be updated
Oct-21-2020
12:24:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  James
McMullenQuery 1: Answered SAE form updated with
latest follow up
Oct-20-2020
03:41:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:O
penedSAE RECON 1: Per latest
SAE listing, gender is still
reported as MALE. Please
confirm if a follow up
AEM form was submitted
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811592
Page 146 of 267
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
to correct gender in Safety
database.
Oct-19-2020
10:28:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered subject is female
Oct-19-2020
05:15:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020403508
,the gender was reported as
MALE in Safety database
but was recorded as
FEMALE in AE CRF.
Please confirm gender. If
safety update is required,
please submit a follow-up
form.
Sep-10-2020
13:24:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 13:24:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 13:24:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
WHITEInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811593
Page 147 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020 13:25:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811594
Page 148 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020 13:26:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020 13:26:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020 13:26:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
COMPLETEDInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811595
Page 149 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020 13:27:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Anxiety
Start Date: Sep/13/20
18
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:27:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 13:27:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
AnxietyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-10-2020 13:27:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/13/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811596
Page 150 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-10-2020 13:27:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-10-2020 13:27:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Hypertensi
on
Start Date: Sep/14/20
12
Ongoing: YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811597
Page 151 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:27:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 13:27:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020 13:27:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/14/2012Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020 13:27:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-11-2020 12:39:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:3
Medical History
Term:mennorrh
agia
Start Date: Apr/18/2
019Transcription
Error
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811598
Page 152 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: YES
Sep-10-2020 13:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical Hi
story Term
:mennorrhagia
with irregular c
ycle
Start Date: Apr/18/2019
Ongoing: YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811599
Page 153 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-12-2020
05:44:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Sep-11-2020
12:39:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Sep-11-2020
12:39:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
menn
orrha
giaTranscription Error
Sep-11-2020
04:49:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedMultiple concepts in
the term
MENNORRHAGIA
WITH
IRREGULAR
CYCLE. Split the
term into
MENORRHAGIA
and IRREGULAR
MENSTRUAL
CYCLE and submit
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811600
Page 154 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
separately. Thank
you.
Sep-10-2020
13:29:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Neha Upadhyay Data
Entry
:
menn
orrha
gia wi
th irre
gular
cycleInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020 13:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Apr/18/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020 13:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-14-2020 10:55:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:seasonal all
ergies
Start Date: Dec/3/201
2
Ongoing: YESTranscription
Error
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811601
Page 155 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-10-2020 13:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Allergy
Start Date: Dec/3/2
012
Ongoing: YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811602
Page 156 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020 13:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020
10:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Patricia
BancheroQuery 1: Closed Response satisfies
query
Sep-14-2020
10:55:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-14-2020
10:55:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesTranscription Error
Sep-11-2020 14:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Patricia
BancheroQuery 1: Opened GPDCLIN: Please
consider updating
the verbatim term
including type of
allergy/allergen.
Sep-10-2020
13:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020 13:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Dec/3/2012Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811603
Page 157 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020 13:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-14-2020 10:56:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:5
Medical
History T
erm:IRREGULAR
MENSTRUAL
CYCLE
Start Date
:Apr/18/2019
Ongoing: YESChanged
Information
Sep-11-2020 12:40:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:irregular c
ycle
Start Date: Apr/18/20
19
Ongoing: YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811604
Page 158 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Sep-11-2020 12:40:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020
11:46:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1:
ClosedDiscrepancy
has been
closed.
Sep-14-2020
10:56:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredChanged
Information
Sep-14-2020
10:56:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
IRREGU
LAR ME
NSTRUA
L CYCLEChanged
Information
Sep-12-2020
05:51:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1:
OpenedClarify
IRREGULAR
CYCLE as
follows... term
is unclear.
Please edit term
to clairfy the
type of cycle. If
reporting
IRREGULAR
MENSTRUAL
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811605
Page 159 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
CYCLE, edit
and submit as
such.
Otherwise,
please edit
term. Thank
you.
Sep-11-2020
12:40:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
irregular c
ycleInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-11-2020 12:40:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/18/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-11-2020 12:40:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-14-2020 10:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:menopause
Start Date: UNK/UNK/
2019
Ongoing: YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811606
Page 160 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Sep-14-2020 10:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020 10:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
menopauseInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-14-2020 10:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-14-2020 10:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811607
Page 161 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
127.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811608
Page 162 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.8Initial Entry
7.a
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Record Identifi
er::1
Temperature: 97.8
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811609
Page 163 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-10-2020 13:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811610
Page 164 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811611
Page 165 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sponsor-Defined
Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-10-2020 13:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811612
Page 166 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020 13:33:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 13:33:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
256095Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811613
Page 167 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 13:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 13:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 09:20:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 04:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-10-2020 13:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811614
Page 168 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-10-2020 13:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 09:20:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3FWInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 09:20:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3FWInitial Entry
5.b
Date Location User Value Reason
Sep-11-2020 09:20:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3FXInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020 09:20:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3FXInitial Entry
5.c
Date Location User Value Reason
Sep-11-2020 09:23:17
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Sample ID: BPY3FVInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811615
Page 169 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
5.c Sample ID
Date Location User Value Reason
Sep-11-2020 09:23:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3FVInitial Entry
5.d
Date Location User Value Reason
Sep-11-2020 09:24:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLF56Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-11-2020 09:24:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLF56Initial Entry
5.e
Date Location User Value Reason
Sep-11-2020 09:25:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLF4SInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-11-2020 09:25:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLF4SInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811616
Page 170 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 13:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 13:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 08:54:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 04:36:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-10-2020 13:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811617
Page 171 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-10-2020 13:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 08:54:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3G3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 08:54:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3G3Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811618
Page 172 of 267
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/10/2020 12:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811619
Page 173 of 267
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811620
Page 174 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 13:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811621
Page 175 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020 09:12:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811622
Page 176 of 267
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 09:13:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020 09:13:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 98.4
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 09:13:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-01-2020 09:13:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811623
Page 177 of 267
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-01-2020 09:13:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-01-2020 09:13:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811624
Page 178 of 267
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
3. Collection Date:
Date Location User Value Reason
Oct-01-2020 09:14:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-01-2020 09:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
Oct-01-2020 09:14:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Def
ined Identifi
er:
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020 09:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811625
Page 179 of 267
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
6.a Test:
Date Location User Value Reason
Oct-01-2020 09:14:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-01-2020 09:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811626
Page 180 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 09:15:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 09:15:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 11:01:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 09:15:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-01-2020 09:15:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811627
Page 181 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-01-2020 11:01:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3PYInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 11:01:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3PYInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811628
Page 182 of 267
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020 11:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811629
Page 183 of 267
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-01-2020 09:15:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811630
Page 184 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020 13:14:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Oct/28/2020Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811631
Page 185 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 13:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 13:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 14:26:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 13:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-28-2020 13:14:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
YES
Date of Collection:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811632
Page 186 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-28-2020 14:26:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNV0MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 14:26:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNV0MInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 14:34:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNV0CInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 14:34:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNV0CInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 14:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7XLBInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 14:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7XLBInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811633
Page 187 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d
Date Location User Value Reason
Oct-28-2020 14:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7XLCInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-28-2020 14:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7XLCInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811634
Page 188 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020
10:35:38 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-16-2020
10:35:05 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-16-2020
10:34:25 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Nov-16-2020
10:34:25 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Nov-16-2020
10:34:25 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Nov/16/2020Initial Entry
3. COVID-19 Illness Visit:
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811635
Page 189 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Nov-16-2020 10:34:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811636
Page 190 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-16-2020
10:36:18 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-16-2020
10:35:05 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened All symptoms are
reported as Not
Present and there
is no Other
Symptom
reported. Please
review and update
as appropriate.
Nov-16-2020
10:35:05 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Nov/16/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Nov/12/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NO
Date of Last Symptom Res
olved:
Nov/16/2020Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811637
Page 191 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.a
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811638
Page 192 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.b Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811639
Page 193 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.d
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811640
Page 194 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.e Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Prese
nt:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811641
Page 195 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.g
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811642
Page 196 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.h Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-16-2020 10:35:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
5.a
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811643
Page 197 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Nov-16-2020 10:36:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms - Othe
r:Headach
eInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-16-2020 10:36:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
HeadacheInitial Entry
5.b
Date Location User Value Reason
Nov-16-2020 10:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms - Other
:Fatigu
eInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-16-2020 10:36:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
FatigueInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811644
Page 198 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811645
Page 199 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Nov/13/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811646
Page 200 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
ABBOTT MOLECULAR R
EALTIME SARS-COV-2 A
SSAYInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-16-2020 10:35:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEGATIVEInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811647
Page 201 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-16-2020 10:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-16-2020 10:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020
19:45:36 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-17-2020
07:20:24 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Nov-16-2020
10:35:38 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811648
Page 202 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
appropriate.
Nov-16-2020
10:35:38 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YES
Date of Collection:
Nov/16/2020Initial Entry
5.a
Date Location User Value Reason
Nov-17-2020 19:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sample ID: CV14381Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 19:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
CV14381Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811649
Page 203 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-16-2020 10:35:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-16-2020 10:35:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-16-2020 10:35:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-16-2020 10:35:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Site did not collect swabInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811650
Page 204 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Vis
its or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Practit
ioner:EMERGE
NCY ROO
M
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811651
Page 205 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Prac
titioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or C
ontacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811652
Page 206 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Prac
titioner:URGENT C
ARE
Occurrence
of Visits or
Contacts:YES
Number of
Visits or Co
ntacts:
1Initial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YES
Number of Visits or Contac
ts:
1Initial Entry
1.e
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Prac
titioner:TELEPHON
E CONSULT
ATIONInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811653
Page 207 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Occurrence
of Visits or C
ontacts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
TELEPHONE CONSULTAT
IONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Practitioner
:OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811654
Page 208 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-16-2020 10:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811655
Page 209 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/16/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-16-2020 10:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-16-2020 10:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 10:36:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
1Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811656
Page 210 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-15-2020 12:02:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Dec/15/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-15-2020 12:02:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
COVID_A1Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811657
Page 211 of 267
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-15-2020 12:02:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-15-2020 12:02:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-16-2020 11:54:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-16-2020 05:30:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-15-2020 12:02:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-15-2020 12:02:49
(UTC-06:00) CentralACV0PFEINFP6000  Fredrick
OkworiData Entry:
YESInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811658
Page 212 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) Date of Collection:
Dec/15/2020
5.a
Date Location User Value Reason
Dec-16-2020 11:54:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Sample ID: BSGTWDInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-16-2020 11:54:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
BSGTWDInitial Entry
5.b
Date Location User Value Reason
Dec-16-2020 11:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Sample ID: BSGTWVInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-16-2020 11:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
BSGTWVInitial Entry
5.c
Date Location User Value Reason
Dec-16-2020 11:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Sample ID: BP8H5ZInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811659
Page 213 of 267
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/15/2020Form: 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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Dec-16-2020 11:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
BP8H5ZInitial Entry
5.d
Date Location User Value Reason
Dec-16-2020 11:55:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Sample ID: BP8H60Initial Entry
5.d Sample ID
Date Location User Value Reason
Dec-16-2020 11:55:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
BP8H60Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811660
Page 214 of 267
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-28-2020 13:14:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Oct/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 13:14:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 13:14:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
COMPLETEDInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811661
Page 215 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Corinne
AbrahamForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811662
Page 216 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 15:27:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811663
Page 217 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 15:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811664
Page 218 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 15:37:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811665
Page 219 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 15:39:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811666
Page 220 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 15:41:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811667
Page 221 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-16-2020 15:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811668
Page 222 of 267
***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: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-21-2020 12:27:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenForm Deleted Duplicate AE
Oct-16-2020 15:45:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiForm Created
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811669
Page 223 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-21-2020
22:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-21-2020
12:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Oct-21-2020
12:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Ovarian MassChanged Information
Oct-21-2020
05:05:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020403508,the
term was updated to
'surgical removal of
OVARIAN MASSin
Safety database while
recorded as 'lvis
Mass' in AE CRF.
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811670
Page 224 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Please confirm
correct term.If safety
update is required,
please submit a
follow-up form.
Oct-16-2020
13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
Pelvis MassInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-21-2020 12:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sep/21/2020 UNK:UNKChanged
Information
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
Sep/28/2020 08:16Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
2Initial 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
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811671
Page 225 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 05:12:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Pelvis
Mass: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is
blank.
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811672
Page 226 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NO
Other medically important
serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020 12:27:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
Ovarian mass of unkn
own originChanged
Information
Oct-16-2020 13:12:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:Transcription
Error
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811673
Page 227 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
pelvic mass of unkno
wn origin
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Corinne
AbrahamData Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 13:04:47
(UTC-06:00) CentralACV0PFEINFP6000  Corinne
AbrahamData Entry:
NOInitial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811674
Page 228 of 267
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-19-2020 05:12:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020403508Initial Entry
090177e196ae3d77\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811675
Page 229 of 267
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner 
…[truncated]